Pharmacovigilance Training Tuition

Accredited pharmacovigilance training & regulatory affairs certification. Backed by CPD accreditation & 5 years of alumni success. Live seminars, 100+ new lessons for 2026. Increase salary by $80K–$150K+. 100% money‑back guarantee, 14‑day refund, payment plans available.

Pharmacovigilance & Regulatory Affairs Certification

Advanced International Pharmacovigilance and Regulatory Affairs Certification (APRAC)

    1. Pharmacovigilance & Regulatory Affairs Course Overview

      FREE PREVIEW
    2. Introduction to Drug Safety and PV

    3. School Policy and Student Enrollment Agreement

    4. CME Handout

    5. Live Review Webinar - See discussion for next meeting time

    6. Launching your career in PV

      FREE PREVIEW
    1. Key PV Terminology (Side Effect, Drug Safety, and Risk Terms)

    2. International Regulatory Requirements and Guidelines Overview

    3. Regional Regulatory Requirements (FDA, EMA, Japan, China)

    4. Postmarketing Surveillance (PMS) and Safety Management

    5. Advanced Review of Adverse Event Reporting

    6. GVP - Pharmacovigilance Abbreviations

    1. Evolution of Global Pharmacovigilance Systems

    2. Advanced Adverse Event Detection Techniques

    3. Expedited Reporting Timelines and Strategies in Pharmacovigilance

    4. Aggregate Safety Reporting Best Practices

    5. Signal Management Lifecycle

    6. Real-World Evidence (RWE) in Signal Detection

    7. Multinational Adverse Event Reporting Challenges

    1. Mapping Global Regulatory Landscape

    2. Drug Approval Pathways – Comparative Review

    3. eCTD Regulatory Submissions

    1. Orphan Drug Exclusivity Protection

    2. Biologics Licensing Applications (BLA)

    3. Generic Drug Approval Pathways (ANDA, RLD) - Global ANDA Regulatory Pathways

    4. Medical Device Directive to MDR Transition

    5. EU IVDR Essentials

    6. Post-Approval Changes Regulation (Type IA, Type IB, and Type II)

    7. Global Over-the-Counter (OTC) Regulatory Frameworks

    8. Controlled Substances Regulatory Challenges

    9. Global Pharmaceutical Law Landscape

    10. Advanced Lifecycle Management

    11. Drug and Device Combination Product Oversight

    1. Advanced Practice of Pharmacovigilance

    2. Additional Encompassing and Confusing Terms in Pharmacovigilance

    3. MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)

    4. Need for Pharmacovigilance

    5. The History of Pharmacovigilance

    6. Roles in Pharmacovigilance

    7. Key Stakeholders in Pharmacovigilance

    8. Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)

    9. Signal Detection (Detection, Validation, Prioritization, and Action)

    10. Risk Assessment, Plan, and Management

    11. Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)

    12. Post-authorization/Post-marketing Regulations in Pharmacovigilance

About this course

  • $495.00
  • 176 lessons
  • Required: Bachelors in Science, Masters, OR PharmD.
  • Length: Length: 165 Hours. Online, self paced, start anytime.
  • Accreditation: CPD. Online certificate. Exam score 70% or higher on 2 attempts.
5 star rating

Unlocked access to a career in Pharmacovigilance

Mohanad Kour

I was having poor luck in applying to PV jobs as my resume was not targeted towards the field. I took the course to add to my resume but found the knowledge review to prepare me for interviews better than my previous training had. Finished in a sh...

Read More

I was having poor luck in applying to PV jobs as my resume was not targeted towards the field. I took the course to add to my resume but found the knowledge review to prepare me for interviews better than my previous training had. Finished in a short time after putting the videos on 2x.

Read Less
5 star rating

Excellent. Five Star

Pooja Naphade

Detailed information about each and every topic. You will get full knowledge on every aspect of Pharmacovigilance and Argus Safety. Highly recommended whoever wants to pursue carrier in respective field.

Detailed information about each and every topic. You will get full knowledge on every aspect of Pharmacovigilance and Argus Safety. Highly recommended whoever wants to pursue carrier in respective field.

Read Less
5 star rating

Fundamental of Pharmacovigilance

Niravkumar Patel

Training was good

Training was good

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5 star rating

APVASC

Trudy Nyarko

Very detailed, it covered all aspect of PV and Argus Safety Database

Very detailed, it covered all aspect of PV and Argus Safety Database

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5 star rating

APVASC

Esther Okorie

It is a great review.

It is a great review.

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5 star rating

Great course!

Sonal Patel

5 star rating

informative

Rajni Patel

very detailed and easy to understand. great learning tool

very detailed and easy to understand. great learning tool

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5 star rating

APVASC COURSE

Joseph Ogedengbe

Quite comprehensive.

Quite comprehensive.

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5 star rating

An excellent and professional course

Ayat Al Naqeeb

5 star rating

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)

Alireza Minagar

Excellent and detailed course

Excellent and detailed course

Read Less
5 star rating

PV and Argus Safety certification course

Farid Hasanov

I found it very useful and full-fledged online training course. It covers all features of PV and includes variety of materials with references. I advice to take this course and gain knowledge about PV and Argus Safety program. Thank you very much ...

Read More

I found it very useful and full-fledged online training course. It covers all features of PV and includes variety of materials with references. I advice to take this course and gain knowledge about PV and Argus Safety program. Thank you very much for valuable information.

Read Less
5 star rating

Great content!

Alejandra Rojas

APRAC Alumni Outcomes

See Where Our APRAC/APVASC Alumni Work

ACRCC – Pharmacovigilance & Regulatory Pathway Results Details
Employers That Hired Graduates

Novo Nordisk · Moderna · Merck · Eli Lilly · AbbVie · Bristol Myers Squibb · Regeneron · Thermo Fisher Scientific · Abbott · Procter & Gamble · Parexel · IQVIA · Accenture · FDA · NIH · U.S. VA · MOH Ontario · CVS · Walgreens · GoodRx · Memorial Sloan Kettering Cancer Center · NewYork-Presbyterian Hospital · Johns Hopkins Medicine · Tufts Medical Center · Beth Israel Deaconess · UF Health Cancer Center · MD Anderson Cancer Center · Emory Healthcare · Northwestern Medicine · L’Oréal
Roles Graduates Secured After the Course Regulatory Affairs Associate · Regulatory Affairs Manager · Regulatory Project Manager · Regulatory Affairs Supervisor & QPPV · Qualified Person Responsible for Pharmacovigilance (QPPV) · Pharmacovigilance Scientist · Senior / Principal Pharmacovigilance Scientist · Pharmacovigilance Manager · Senior Pharmacovigilance Associate · Drug Safety Specialist · Patient Safety Senior Associate · Product Safety Manager · Epidemiologist · Medical Affairs Senior Scientist · Senior Medical Advisor · QA & Medical Complaint Handling Associate · Senior Director Quality · Vice President Medical Affairs · Vice President Clinical Development · Senior Director Clinical Operations & Safety · Clinical Guidelines Coordinator · Clinical Data Monitor · Operation Specialist (Life-Cycle Safety / Drug Safety) · Pharmacy Manager · Clinical Pharmacist Consultant · COVID Health Specialist — Case & Contact Manager

ADVANCED PHARMACOVIGILANCE AND REGULATORY AFFAIRS CERTIFICATION (APVASC)

Master Pharmacovigilance and Regulatory Affairs in 4-10 Weeks. Start Managing Drug Safety and Global Submissions at Pharmaceutical Companies, CROs, and Regulatory Agencies. Prior Clinical Research Experience Required.

WHAT YOU'LL LEARN

  • Master adverse event reporting, signal detection, and risk management plan development.

  • Execute pharmacovigilance case processing from intake through regulatory submission.

  • Prepare IND, NDA, MAA, and post-marketing surveillance submissions for FDA, EMA, and global agencies.

  • Implement ICSR processing, MedDRA coding, and causality assessment workflows.

  • Coordinate Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURPs), and Risk Evaluation and Mitigation Strategies (REMS).

  • Manage pharmacovigilance audits, regulatory inspections, and compliance documentation.

  • Navigate global regulatory frameworks including FDA, EMA, MHRA, PMDA, and ICH guidelines.

  • Lead drug safety teams, vendor oversight, and cross-functional regulatory strategy.




PROGRAM DESCRIPTION

The APVASC program is a CPD-accredited, 100% online pharmacovigilance certification designed to make you job-ready as a PV specialist or regulatory affairs professional in weeks, not years.

You will complete 170+ comprehensive lessons covering every aspect of drug safety and regulatory submissions. Work through 400+ real-world case studies pulled from actual adverse event reports and regulatory filings. Attend live webinars with expert pharmacovigilance specialists who manage safety operations daily.

Graduate with CPD accreditation recognized by pharmaceutical companies, CROs, and regulatory agencies worldwide. Earn URL-verified pharmacovigilance certification accepted for hiring and credentialing. Receive downloadable safety templates, ICSR processing guides, and regulatory submission checklists you can use immediately.

Complete in 4-10 weeks depending on your pace. You get lifetime access to all materials and quarterly updates at no additional cost.




WHY PHARMACOVIGILANCE AND REGULATORY AFFAIRS TRAINING MATTERS

Pharmacovigilance specialists and regulatory affairs professionals are critical to drug development and patient safety.

Pharmaceutical companies desperately need qualified safety professionals who understand adverse event reporting, signal detection, risk management, and global regulatory submissions. Without proper training, aspiring PV specialists lack the practical skills sponsors demand from day one.

Generic safety courses teach surface-level theory without real case processing workflows. University programs cost $8,000 to $20,000 and take 6-12 months. Basic webinars provide completion certificates with no accreditation or employer recognition.

APVASC solves this gap with application-based training covering every task pharmaceutical companies expect. You graduate with CPD accreditation employers recognize for hiring and promotion in pharmacovigilance and regulatory affairs roles.



THREE BIGGEST OBSTACLES TO BREAKING INTO PHARMACOVIGILANCE

No Clear Entry Path Into Drug Safety


You have healthcare, pharmacy, or life sciences background but no idea how to break into pharmacovigilance. Job postings require PV experience you cannot get without breaking into safety roles. You need formal training that bridges clinical knowledge to drug safety competencies.

Theory-Only Programs That Skip Practical Application


You completed basic safety courses that taught regulations but not real case processing. You still do not know how to assess causality, code adverse events in MedDRA, or write Individual Case Safety Reports (ICSRs). Employers want job-ready specialists who can process cases immediately.

No Credentials Pharmaceutical Companies Recognize


You attended webinars or workshops that gave attendance certificates with no accreditation. Pharmaceutical companies and CROs do not accept these for hiring. You need certification with CPD credits that satisfies compliance requirements and demonstrates verified competency.

Most aspiring pharmacovigilance specialists waste months trying different programs, spending thousands of dollars, and still not qualifying for safety positions.

If you do not get proper training now, you will watch peers with formal certification get hired while you remain stuck, missing out on $65,000 to $110,000+ annual salaries in one of pharma's fastest-growing fields.




WHY APVASC IS THE SMARTEST CHOICE FOR YOUR PV CAREER

Start managing drug safety within weeks, not years.

Get job-ready safety tools you can use immediately.

Earn CPD-accredited pharmacovigilance certification employers actually recognize.

Learn from practicing PV specialists who manage safety operations daily.

Join 10,000+ alumni working at leading organizations.

Optional mentorship for personalized career guidance.

Flexible learning that fits your schedule.

Proven results.




WHY OTHER PROGRAMS FALL SHORT

University PV programs cost $8,000 to $20,000 with limited access.


You pay premium prices but receive no CPD credits, no lifetime access, and minimal practical case processing. Curriculum focuses on drug development theory, not safety operations skills pharma needs.

Basic safety webinars provide certificates with no value.


You complete 2-hour sessions covering elementary concepts with no depth, no accreditation, no employer recognition for actual hiring decisions.


Association memberships offer resources but not training.


You pay annual dues for access to guidelines and networking but receive no structured curriculum, no case simulations, no certification exam validating competency.





MEET YOUR LEAD INSTRUCTOR

Vinil Samuel Jayaseelan, MSc, leads the APVASC program with over 9 years of hands-on experience across pharmacovigilance, drug safety, and medical information operations supporting pharmaceutical companies, CROs, and healthcare organizations.

Former Drug Safety and Medical Information Specialist and Drug Safety Associate with extensive experience managing end-to-end adverse event reporting, case processing, and safety surveillance across clinical trials, post-marketing, literature, and consumer product settings. Processed and quality reviewed 2,000+ ICSRs across solicited, spontaneous, regulatory, and clinical trial sources, supported signal detection activities, and authored safety narratives aligned with ICH E2B, GVP, and global regulatory requirements. Experienced with FDA, MHRA, Health Canada, and EU regulatory frameworks, including audit support, CAPA participation, SOP authoring, and inspection readiness. 

Vinil contributed to the design of APVASC by aligning the syllabus directly with real-world pharmacovigilance workflows, including case intake, MedDRA and WHO-DD coding, expedited and periodic reporting, quality control review, reconciliation activities, medical information handling, and safety system usage such as Oracle Argus and Medidata. The curriculum reflects the exact competencies expected in sponsor and CRO safety teams rather than theoretical overviews.

Senior pharmacovigilance mentors include drug safety managers, medical information leads, and regulatory safety professionals with 10+ years managing global adverse event operations, audits, and safety compliance. All mentors have trained and supervised safety associates and understand sponsor and regulatory expectations for PV roles from day one.




MAKE IT RISK-FREE

14-Day Money-Back Guarantee


If you are unsatisfied for any reason within first 14 days, request full refund. No questions asked.

Two Exam Attempts Included


Pass 50-question competency exam with 70% or higher. Review feedback and retake if needed with no waiting period or additional fee.

Flexible Payment Plans Available


Spread program cost over multiple months to fit your budget.

Lifetime Access to All Materials and Updates


No expiration, no recurring fees, no additional costs for updates or new content.




WHO THIS COURSE IS FOR

  • Pharmacists transitioning to drug safety.

  • Life sciences graduates seeking PV careers.

  • Clinical research professionals expanding to safety.

  • Regulatory affairs professionals adding PV skills.

  • Healthcare workers exploring drug safety careers.




FREQUENTLY ASKED QUESTIONS

Do I need prior pharmacovigilance experience to enroll in this pharmacovigilance training course?

No. APVASC pharmacovigilance training course is designed for healthcare professionals, pharmacists, and life sciences graduates with no PV experience. The program starts with foundational safety principles and builds to advanced signal detection and risk management. Many successful graduates were pharmacists, nurses, or clinical research professionals before enrolling.

How long does it take to complete the pharmacovigilance certification online?

Completion time depends on your pace. Fast-track students finish in 4-6 weeks studying 20-25 hours weekly. Moderate pace students finish in 8 weeks studying 12 hours weekly. Extended timeline students finish in 10 weeks studying 8 hours weekly. You have lifetime access with no deadline to complete.

Is this pharmacovigilance certification online recognized by pharmaceutical companies?

Yes. APVASC pharmacovigilance certification online is CPD-accredited and aligned with FDA, EMA, MHRA, PMDA, and ICH guidelines. Pharmaceutical companies, CROs, and regulatory agencies accept APVASC for hiring and credentialing requirements. Your certificate includes URL verification allowing employers to validate authenticity instantly.

What is the difference between Standard and Mentorship Plus packages?

Standard Package ($495) includes all 170+ lessons, live webinars, templates, certification exam, and lifetime access. Mentorship Plus ($1,485) adds six private 1-to-1 coaching calls covering resume review, interview preparation, salary negotiation, and strategic career planning with senior pharmacovigilance professionals.

What if I don't pass the certification exam?

You have two attempts to pass the 50-question exam with 70% or higher score. If you don't pass on first attempt, review the targeted feedback showing weak areas and retake when ready. There is no waiting period between attempts. Most students pass on first try after completing all lessons and case studies.




READY TO START YOUR PHARMACOVIGILANCE CAREER?

Standard Package: $495


170+ lessons, live webinars, 400+ case studies, 100+ templates, certification exam, CPD accreditation, lifetime access, 24/7 support.

Mentorship Plus: $1,485


Everything in Standard plus six coaching calls, resume review, mock interviews, career planning, priority access, mentor email support.

Contact Us:




Pharmacovigilance & Regulatory Affairs Curriculum Overview

Skills & Objectives for Each Pharmacovigilance & RA Chapter

Module Objectives & Skills
Introduction: Pharmacovigilance & Regulatory Affairs Course Overview, Introduction to Drug Safety and PV, School Policy and Student Enrollment Agreement, Live Review Webinar • Orient to course structure, requirements, and enrollment policies;
• Master core PV terminology and drug‑safety concepts;
• Navigate live‑session formats.
CH 1. Fundamentals of Global Pharmacovigilance: Key PV Terminology (Side Effect, Drug Safety, Risk Terms), International Regulatory Requirements and Guidelines Overview, Regional Regulatory Requirements (FDA, EMA, Japan, China), Postmarketing Surveillance (PMS) and Safety Management, Advanced Review of Adverse Event Reporting, GVP Abbreviations • Define and apply essential PV and risk‑management terminology;
• Compare global and regional regulatory frameworks (FDA, EMA, PMDA, NMPA);
• Design and oversee PMS programs and safety‑management plans;
• Execute advanced AE‑reporting workflows and use GVP shorthand effectively.
CH 2. Evolution & Reporting: Evolution of Global Pharmacovigilance Systems, Advanced Adverse Event Detection Techniques, Expedited Reporting Timelines & Strategies, Aggregate Safety Reporting Best Practices, Signal Management Lifecycle, Real‑World Evidence (RWE) in Signal Detection, Multinational Adverse Event Reporting Challenges • Chart the development of PV systems from spontaneous reporting to RWE‑driven models;
• Implement expedited (15‑day, 7‑day) and aggregate (PSUR/PBRER) reporting processes;
• Manage signal‑lifecycle steps—detection, validation, prioritization, action;
• Address cross‑border ICSR‑reporting nuances and leverage RWE for early signal insight.
CH 3. Foundational Frameworks: Mapping Global Regulatory Landscape, Drug Approval Pathways – Comparative Review, eCTD Regulatory Submissions • Map and contrast FDA, EMA, PMDA, NMPA, and MHRA approval pathways;
• Prepare and assemble eCTD submission modules with lifecycle‑management best practices;
• Advise on dossier harmonization across regions.
CH 4. Regulatory Knowledge: Orphan Drug Exclusivity Protection, Biologics Licensing Applications (BLA), Generic Drug Approval Pathways (ANDA/RLD), Medical Device Directive → MDR Transition, EU IVDR Essentials, Post‑Approval Changes (Type IA/IB/II), Global OTC Frameworks, Controlled Substances Challenges, Global Pharma Law, Lifecycle Management, Combination‑Product Oversight • Navigate special‑status pathways (orphan, 505(b)(2), ANDA) and exclusivity rules;
• Manage device‑and‑drug combination regulatory pathways;
• Implement post‑approval submission types and maintain global OTC compliance;
• Interpret pharmaceutical‑law differences and lifecycle‑management strategies.
CH 5. Advanced PV Review: Advanced Practice of Pharmacovigilance, Confusing PV Terms, MedDRA (Hierarchy, Searching, Exporting), Need & History of PV, PV Roles & Stakeholders, ICSR Case Processing & Narrative Writing, Aggregate Reporting, Signal Detection & Risk Management, COVID‑19 Vaccine Surveillance (AEFI/AESI), Post‑Authorization PV Regulations • Apply MedDRA coding for ICSR intake and narrative craftsmanship;
• Coordinate stakeholder roles from MAH to HCP to patient;
• Develop aggregate‑reporting plans and risk‑management frameworks;
• Conduct vaccine‑safety surveillance and AEFI case studies;
• Ensure compliance with ongoing PV‑regulation updates.
CH 6. Argus Safety Certification: Argus Safety Database Certification Parts 1–6, Oracle Argus Safety User Guide, Basic Argus Walkthrough • Configure Argus environments and user profiles;
• Process ICSRs—from data entry through medical review;
• Generate safety‑reporting outputs and perform case‑line reviews;
• Leverage Argus query, workflow, and reporting functionalities.
CH 7. Specialized PV Areas: Vaccine‑Related AEFI Surveillance, Drug‑Drug Interaction Signal Monitoring, Pharmacogenomics & Personalized Safety, Pediatric & Neonatal PV Practices, Biologics PV, Orphan‑Drug AE Monitoring, Case Narrative Writing, Ethics in Safety Communication • Implement age‑ and population‑specific PV methodologies;
• Conduct DDI and pharmacogenomic safety profiling;
• Craft clear, ethical AE narratives;
• Manage orphan‑drug‑specific surveillance and communicate safety to vulnerable groups.
CH 8. Advanced Tools & Techniques: EudraVigilance Fundamentals, RMM Design, MedDRA Coding Expertise, Data‑Mining Algorithms for AE Detection, Real‑Time EHR Surveillance, FDA MedWatch Platform • Execute signal detection in EudraVigilance and FDA MedWatch;
• Design and evaluate RMMs (Risk Minimization Measures);
• Apply data‑mining and EHR‑analytics tools for proactive surveillance;
• Advance MedDRA proficiency for complex queries.
CH 9. Global Alignment & Strategy: EU GVP Module Deep‑Dive, US FDA PV Requirements, ICH E2 Series, Post‑Brexit MHRA PV Regulations, PV Audits & Inspections Roadmap, Cross‑Border Data Sharing • Interpret and apply GVP Modules I–X;
• Implement ICH E2A–E2F reporting requirements;
• Adapt to UK‑EU PV divergence;
• Prepare for regulatory audits and enable compliant international data exchanges.
CH 10. Emerging PV Trends: Blockchain in PV, Social‑Media Signal Detection, Big‑Data Integration, Mobile‑Health Surveillance, Leadership in PV • Pilot blockchain for consent and data‑integrity;
• Leverage social‑listening for early signals;
• Integrate big‑data platforms and mHealth telemetry;
• Cultivate leadership for innovative PV teams.
CH 11. Submission Specializations: eCTD Lifecycle Management, Clinical‑Trial Dossier Development, Accelerated Approval Pathways, Post‑Market Variation Strategy, Product‑Recall RA Role, Comparative Labeling, Vaccine Submission, DMF/ASMF Process, FDA Advisory Committees, Compassionate Use & Expanded Access • Manage end‑to‑end eCTD planning and validation;
• Coordinate accelerated and variation submissions;
• Advise on labeling harmonization and recall procedures;
• Navigate US AC meetings and expanded‑access programs.
CH 12. Advanced RA Strategies: Adaptive Licensing & Flexibility, ATMP Regulatory Oversight, FDA Project Orbis, Pediatric‑Drug Development, Blockchain for RA Compliance, SaMD Regulation, Patient‑Focused Outcome Assessment Regulations, Biosimilars Considerations • Design adaptive licensing submissions and gain regulatory buy‑in;
• Oversee ATMP and cell‑therapy product filings;
• Engage with global pilot initiatives (Orbis);
• Ensure SaMD and biosimilars compliance;
• Incorporate patient‑focused measures in submissions.
CH 13. Leadership & Risk Management: Regulatory‑Affairs Leadership Frameworks, Stakeholder Management, Inspection‑Risk Assessment, Cross‑Border Team Coordination, Agile‑Regulatory Teams, Virtual‑Trial Oversight, Career Pathways, Proactive Risk Communication, Crisis Management, Ethics & TQM, Digital‑Era Oversight, Future RA Challenges  • Lead cross‑functional RA teams with agile methodologies;
• Assess and mitigate inspection risks;
• Coordinate remote and international regulatory operations;
• Implement TQM and ethical decision‑making;
• Strategize for future regulatory landscapes.
CH 14. Specialized RA Techniques: Risk Communication for Vulnerable Populations, Adaptive Signal Management, Global AE‑Management Across Affiliates, Data Standardization in Drug Safety, PV SOP Best Practices, Signal‑Management Automation, Safety‑Reporting for Digital Therapeutics, SaMD Governance • Tailor risk messages for diverse audiences;
• Automate signal workflows and standardize safety data;
• Govern PV for digital‑therapeutic and software‑as‑medical devices.
CH 15. Quality Fundamentals & Standards: Global QA Standards, QMS Development, GMP Essentials, SOP Creation, QA Audit‑Readiness, Good Documentation Practices, Deviation Management & CAPA, CMO Audit Processes, Validation & Qualification, FMEA Risk Analysis • Establish and maintain QMS and GMP compliance;
• Draft SOPs and GDPs;
• Prepare for QA audits and implement FMEA for quality‑risk analysis;
• Manage CAPA across CMOs.
CH 16. Specialized QA Processes: QbD Principles, Analytical Method Validation, GDP Audits, QC Testing, Aseptic‑Processing Sterility, Data Integrity QA, Vendor Qualification & Audits, Environmental Monitoring, Medical‑Device QSR, Batch‑Record Reviews • Embed QbD in product development;
• Validate analytical methods;
• Audit distribution and QC labs;
• Ensure aseptic‑processing integrity;
• Oversee vendor‑qualification and environmental‑monitoring programs.
CH 17. QA Leadership & Trends: QA Leadership Essentials, Continuous Quality Improvement, Digital‑Quality Tools, Emerging QA Trends, Ethics & Integrity in QA • Cultivate QA leadership and CQI programs;
• Deploy digital‑quality dashboards;
• Navigate evolving QA regulations with ethical rigor.
CH 18. Resources: International PV Guidelines (EMA, WHO‑ISoP), DIA PV Competencies, Career Resources, E2E PV Planning, GVP XVI Addendum, GVP Modules I–XVI (Systems, Inspections, Signal Management, PSUR, RMM, PSMF, Safety Communication) • Access and apply global PV reference materials;
• Align competencies to industry standards;
• Leverage GVP Module guidance for system setup, audits, and risk‑minimization.
CH 19. Practice Exams: Pharmacovigilance Quiz ×4, Pharmacovigilance Final Exam • Reinforce mastery through iterative practice;
• Identify knowledge gaps and cement exam‑readiness.
Certification Exam: Pharmacovigilance & Regulatory Affairs Exam Study Guide, Pharmacovigilance Competency Exam • Demonstrate comprehensive PV and RA competence;
• Achieve APRAC certification through rigorous assessment.

CCRPS Reviews for Pharmacovigilance Training

5 star rating

Gained more knowledge through application

Harneet Jawanda

I was hoping to get more knowledge about pharmacovigilance and drug safety to transition from my career as a CRC and I actually got a lot more, as we were not only given information related to each regulatory body but also very useful examples of ...

Read More

I was hoping to get more knowledge about pharmacovigilance and drug safety to transition from my career as a CRC and I actually got a lot more, as we were not only given information related to each regulatory body but also very useful examples of applicability and some non-compliance cases. The teachers had excellent presentation skills of all the proposed topics, including the most complex ones from a regulatory point of view. The analytic method facilitated my understanding of some critical rules and laws for pharmacovigilance.

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5 star rating

Great pharmacovigilance training for beginners

Kayode Akamo

I was referred by a friend in the field to take this course before I applied to jobs in regulatory affairs. The course starts with a few short introductory modules that cover everything you need to know. THEN it goes into immense depth with great ...

Read More

I was referred by a friend in the field to take this course before I applied to jobs in regulatory affairs. The course starts with a few short introductory modules that cover everything you need to know. THEN it goes into immense depth with great explanations of everything you'll need to know.

Read Less
5 star rating

Global Fundamentals of Pharmacovigliance

Kenechi Ejebe

5 star rating

ALL

Adetunji Ojo

Well explained course by the Lecturers, made the concept of PV very simple to understand. I eagerly looking forward to hands on experience.

Well explained course by the Lecturers, made the concept of PV very simple to understand. I eagerly looking forward to hands on experience.

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5 star rating

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)

Hamid Suhail

Very informative and easy to understand all slides and presenter.

Very informative and easy to understand all slides and presenter.

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5 star rating

Very informative with many details as possible.

patrick padja

Great and easy to go through.

Great and easy to go through.

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5 star rating

Pharmacovigilance course

ROGER ANDERSEN

Very thorough. Lots of references for EU & US

Very thorough. Lots of references for EU & US

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5 star rating

Accurate

Carla Costilow

Easy to read and follow along

Easy to read and follow along

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5 star rating

Informative for EU drug safety professional

Farbod Davary Moghaddam

It was very informative and really useful training for PV professionals

It was very informative and really useful training for PV professionals

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5 star rating

Excellent Certification Program

Randy Sim

Would recommend for anyone interested in getting quality training in pharmacoviligance.

Would recommend for anyone interested in getting quality training in pharmacoviligance.

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5 star rating

Good

Jeremy Campbell

5 star rating

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)

LINUS AGWUNOBI

The course is well organized and thoroughly taught. I love it!

The course is well organized and thoroughly taught. I love it!

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5 star rating

Unlocked access to a career in Pharmacovigilance

Mohanad Kour

I was having poor luck in applying to PV jobs as my resume was not targeted towards the field. I took the course to add to my resume but found the knowledge review to prepare me for interviews better than my previous training had. Finished in a sh...

Read More

I was having poor luck in applying to PV jobs as my resume was not targeted towards the field. I took the course to add to my resume but found the knowledge review to prepare me for interviews better than my previous training had. Finished in a short time after putting the videos on 2x.

Read Less
4 star rating

Satisfactory

Andrew Isiorhovoja

The course detailed and well package in such a way that anyone can clearly understand the contents.

The course detailed and well package in such a way that anyone can clearly understand the contents.

Read Less
5 star rating

awesome

Monika Devangam Yerra

5 star rating

Advanced International PV and Argus Safety Certification course

Lakshmi Narasimhan

This course was very well organised, with all the relevant information and easy to understand

This course was very well organised, with all the relevant information and easy to understand

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5 star rating

Global Fundamentals of Pharmacovigliance

Kenechi Ejebe

5 star rating

PHARMACOVIGILANBCE

Emmanuel Nubila

5 star rating

PV and Argus Safety certification course

Farid Hasanov

I found it very useful and full-fledged online training course. It covers all features of PV and includes variety of materials with references. I advice to take this course and gain knowledge about PV and Argus Safety program. Thank you very much ...

Read More

I found it very useful and full-fledged online training course. It covers all features of PV and includes variety of materials with references. I advice to take this course and gain knowledge about PV and Argus Safety program. Thank you very much for valuable information.

Read Less
4 star rating

Advanced International Pharmacovigilance Part 2

Stephanie Thiant

Globalement très bien. Je trouve un peu dommage que les présentateurs ne fassent que lire les diapos. Personnellement je préférais les lire moi même que d'écouter la personne. J'aurais aimé que les présentateurs amènent réellement du contenu supp...

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Globalement très bien. Je trouve un peu dommage que les présentateurs ne fassent que lire les diapos. Personnellement je préférais les lire moi même que d'écouter la personne. J'aurais aimé que les présentateurs amènent réellement du contenu supplémentaire, des exemples ou des mises en situation. Ca manquait pour moi d'exemples concrets. Beaucoup de texte parfois sur les diapos qui pourraient être allégées. Souvent des redondances dans le contenu de certaine présentation Les questions des tests ne correspondaient pas toujours au contenu qui venait d'être vu.

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5 star rating

Pharmacovigilance training that is up to date with current Post-COVID practices

mizu bronx

The advanced chapters are informative and was more tailored to my role. I enjoyed the explanation of RMPs, PSURs and remote methods. I liked how the lectures were adapted to what changed and what's not changed. I liked that it drilled in ways to u...

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The advanced chapters are informative and was more tailored to my role. I enjoyed the explanation of RMPs, PSURs and remote methods. I liked how the lectures were adapted to what changed and what's not changed. I liked that it drilled in ways to understand SAE and SUSAR and investigator reporting timelines without being dry. It's a good course to take overall and well worth it for the price.

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5 star rating

Great videos to narrate you through each topic.

Hayden Conyrt

I loved the videos that took you through every presentation and gave many examples to help you apply the knowledge and guidelines. It covers reporting to an extent that you'll never forget. It provides knowledge from the main PV bodies internation...

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I loved the videos that took you through every presentation and gave many examples to help you apply the knowledge and guidelines. It covers reporting to an extent that you'll never forget. It provides knowledge from the main PV bodies internationally so you can easily compare.

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5 star rating

Excellent

Simone Roberts

As a microbiologist, I enjoyed this course very much. One can do it in your own time. It is very detailed and well explained. I will recommend this course to anyone who wants to pursue in pharmacovigilance.

As a microbiologist, I enjoyed this course very much. One can do it in your own time. It is very detailed and well explained. I will recommend this course to anyone who wants to pursue in pharmacovigilance.

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5 star rating

Great Certificate Course

Sso Lee

This is a great certificate course. Overall, the information is very valuable and helpful. Thank you.

This is a great certificate course. Overall, the information is very valuable and helpful. Thank you.

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5 star rating

APVASC

Henry Ogbeifun

5 star rating

Pharmacovigilance

Qudian Cole

Excellent and detailed course

Excellent and detailed course

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4 star rating

Satisfactory

Dr Sayali Kulkarni

5 star rating

Amazing to learn an in-depth knowledge of pharmacovigilance process and the Argus database.

Aman Maharjan

5 star rating

Information given was unbiased.

Kelli Timmer

Information was presented well. More interaction would foster a better understanding of material presented.

Information was presented well. More interaction would foster a better understanding of material presented.

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5 star rating

Title was appropriate.

Ayo Adesanya

The text were legible and outlined the course.

The text were legible and outlined the course.

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5 star rating

Great Course on PV

Shravan Chintala

The curriculum and video presentations are thorough and informative

The curriculum and video presentations are thorough and informative

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5 star rating

Very good

Abigail Oloo

Very good introductory PV course

Very good introductory PV course

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5 star rating

APVASC

Johanne Brim

5 star rating

Pharmacovigilance

Qudian Cole

Excellent and detailed course

Excellent and detailed course

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4 star rating

Satisfactory

Dr Sayali Kulkarni

5 star rating

Title was appropriate.

Ayo Adesanya

The text were legible and outlined the course.

The text were legible and outlined the course.

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5 star rating

Rate

Aliaa Allao

5 star rating

APVASC

Esther Okorie

It is a great review.

It is a great review.

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5 star rating

APVASC

Esther Okorie

It is a great review.

It is a great review.

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5 star rating

APVASC

Trudy Nyarko

Very detailed, it covered all aspect of PV and Argus Safety Database

Very detailed, it covered all aspect of PV and Argus Safety Database

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5 star rating

An Excellent Pharmacovigilance course

Kaakou Pokona

5 star rating

Very concise

Jasmine Muse

Great organization of material and easy to understand.

Great organization of material and easy to understand.

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5 star rating

A

shama hussain

5 star rating

great

Nidhi Bhalodia

5 star rating

awesome

Monika Devangam Yerra

Leading pharmacovigilance and regulatory affairs training with data-driven alumni success

Pharmacovigilance Certification FAQs

Learn more about our leading pharmacovigilance program

1. Pharmacovigilance Certification – How Is APRAC Different From a One-Year Master’s?

Our pharmacovigilance certification condenses the essential skills of a master’s program into 170 guided hours: 40 topics on drug  safety regulations, 20 mock PSUR/DSUR exercises, and 6 live mentor calls (in mentorship plan) all backed by CPD accreditation. You skip semester-long theory blocks and instead practice writing ICSRs, validating MedDRA coding, and defending risk-benefit assessments, so you can step into a Drug Safety Associate role in four weeks, not four semesters.


2. Pharmacovigilance Certification Course Accredited Online – What Outcomes Can I Expect?

This pharmacovigilance certification course accredited online program has students reporting "no interview offers to 5" within a month of completing. Alumni have moved from bench science to PV Scientist, Regulatory Associate, and Pharmacovigilance Manager, thanks to the program’s live résumé lab, interview drills, and lifetime access to vacancy boards.


3. Pharmacovigilance Training – How Are the 100+ Case Simulations Built Into Every Module?

Your pharmacovigilance training day never ends with a passive video. After each concept, signal prioritization, expedited timelines, vaccine AEFI triage, you tackle 2 quick case simulations, review tables (2x repetition with tons of examples to enforce memorization) and 5 MCQs to quickly handle any skill needed in PV. This “learn, do, check” loop cements recall long past exam day.


4. Drug Safety Pharmacovigilance Certification – Which Employers Hire Graduates?

With a drug safety pharmacovigilance certification from APRAC in hand, alumni have landed at more than 1,200 organizations, including Johnson & Johnson, Emory Healthcare, CVS, the U.S. VA, IQVIA, and Johns Hopkins Medicine. Many start as Clinical Trial Drug Safety Associates and grow into Senior PV Scientists within two years.


5. Pharmacovigilance Course – Where Does Argus Safety Fit In?

The core pharmacovigilance course includes a six-part Argus Safety Database Certification and Training: you build user roles, enter mock cases, generate regulatory clock reports, and troubleshoot validation checks—exactly the skills CRO hiring managers test during interviews.


6. Pharmacovigilance Courses – Do I Need Separate Modules for Devices, Vaccines, and Biologics?

No. All specialized pharmacovigilance courses are already bundled: Week 2 dives into medical-device vigilance, biologics AE monitoring, and COVID-era vaccine surveillance, so you graduate comfortable with every product class you’ll see at a sponsor or CRO.


7. Courses on Pharmacovigilance – Can I Sample a Single Topic First?

Yes; our courses on pharmacovigilance offer a demo. Because we aim to only graduate top-level students, we do not allow a-la-carte options.


8. Best Pharmacovigilance Certification in USA – What Gives APRAC That Title?

Learners call it the best pharmacovigilance certification in USA because it blends U.S. law (21 CFR Part 314, VAERS) with EMA and PMDA comparisons and delivers an average $28 k salary lift; verified by 2024 alumni surveys.


9. Pharmacovigilance Certificate Course – What Physical Proof Will I Receive?

Upon passing the proctored exam, the pharmacovigilance certificate course issues:

  1. A URL-Linked PDF diploma (for TMF files)

  2. A LinkedIn badge that links to a skill matrix of completed modules

Auditors scan the QR code to view date-stamped, non-editable verification.


10. Regulatory Affairs Certification – Is This Truly “All-In-One”?

Yes. Your regulatory affairs certification portion covers 60 hours of dossier strategy, label changes, and inspection prep, capped by a live exercise where you write a mock Type IB variation and receive faculty redline comments within 48 hours.


11. Other Regulatory Affairs Training Program vs. APRAC – Key Differences? (or see table above) 

Unlike the CDC regulatory affairs training program, which focuses on U.S. public-health submissions, APRAC adds EU IVDR, China NMPA, and Japan PMDA pathways plus post-marketing change control (Type IA/II). That breadth makes graduates attractive to global manufacturers.


12. Masters Programs in Regulatory Affairs – Why Choose APRAC Instead?

Traditional masters programs in regulatory affairs cost $25-60 k and require 18-24 months. APRAC costs $495, finishes in four to sixteen weeks (or longer if part time), includes 10 hours of personal coaching (mentorship package), and still covers eCTD lifecycle management, orphan-drug exclusivity, and combination-product oversight.


13. Regulatory Affairs Certificate – Does APRAC Satisfy Employer CE Requirements?

Yes. The APRAC diploma doubles as a regulatory affairs certificate backed by CPD hours credits that many pharma and device companies now require for annual compliance.


14. Certificate in Regulatory Affairs – How Detailed Are the Quality & GMP Sections?

The certificate in regulatory affairs embeds a 60-lesson quality track: you build a QMS, draft SOPs, perform mock FMEA on a sterile filling line, and write a CAPA plan in response to a fictional FDA 483—skills that QA leaders want from day one.


15. Regulatory Affairs Certification Online – How Do We Keep It Interactive?

Despite being a regulatory affairs certification online, you attend live Q&As, engage with peer cohort, and present your labeling-change rationale to an instructor who has signed more than 100 real FDA submissions.


16. Regulatory Affairs Courses – Can I Focus on Pediatric or Orphan-Drug Pathways?

Certainly. Within the master list of regulatory affairs courses, Week 3 offers deep dives into pediatric-vaccine dossiers, PIP requirements, and orphan-drug market-exclusivity strategy, essential if you target rare-disease employers like BioMarin or Vertex.


17. Regulatory Certification – How Does the Exam Validate Competence?

To earn the regulatory certification, you must score 70 % on a 50-question, scenario-based exam (two attempts allowed). Questions mix PV and RA: interpret a MedDRA code list, outline PSUR timelines, and draft a post-approval CMC supplement summary.


18. Regulatory Affairs Course – Does It Cover Post-Marketing Variations?

Yes. The Week 3 regulatory affairs course walks you through Type IA, IB, and II variations with practice forms, justification templates, and a simulation where you respond to fictional agency questions within a 24-hour deadline.


19. Regulatory Affairs Classes – How Are Leadership and Communication Skills Taught?

Our regulatory affairs classes dedicate eight lessons to stakeholder management: crafting clear risk-communication emails, chairing cross-functional meetings, and rehearsing inspection opener statements, all crucial soft skills for RA leads.


20. Regulatory Affairs Training – What Support Continues After Graduation?

Lifetime regulatory affairs training benefits include quarterly micro-update modules, alumni mastermind groups, a private job board, and free resume re-reviews anytime your career goals shift.


Quick-Glance Course Snapshot 

Feature Detail
Total Lessons / Modules 170+ lessons, 170+ advanced modules
Course Length 170 hours (4-16 week fast track or self-paced)
Interactive Elements 100+ case simulations, 500 MCQs, Argus Safety, database, MCQs, live webinars
Accreditation CPD & ACPE 
Exam 50 questions, proctored, 70 % pass (2 attempts)
Price / Guarantee $495 (or 3 × $500 mentorship plan), 14-day money-back
Graduate Employers Moderna, FDA, AbbVie, IQVIA, Memorial Sloan Kettering, Walgreens, NIH, etc.
Typical Salary Lift $80 k–$150 k career range

Regulatory Affairs Certification and Drug Safety Certification

Get cutting-edge training with a track record of graduate success. Enroll instantly. 100% Online and Self Paced. Reoccurring Live Seminars. 100% Money-back Guarantee with 14 Day Refund Policy. Payment Plans Available.