Accredited and Industry-recognized pharmacovigilance training & regulatory affairs certification with unmatched curriculum. Weekly live seminars and 100+ new lessons for 2025 to stay ahead and stand out. Increase salary potential by $80-150k+. 100% Money-back Guarantee with 14 Day Refund Policy. Payment Plans Available.
171 In-Depth Advanced CRA Training Modules ($1299 Value) + 10000s Toolks/Quizes/Examples + Certification Exam Backed by CPD + CME Credits. Lifetime Access to Unmatched Curriculum.
+ 1-1 Mentorship
+ Career Accelerator
Advanced International Pharmacovigilance and Regulatory Affairs Certification (APRAC)
Pharmacovigilance & Regulatory Affairs Course Overview
FREE PREVIEWIntroduction to Drug Safety and PV
School Policy and Student Enrollment Agreement
CME Handout
Live Review Webinar - See discussion for next meeting time
Key PV Terminology (Side Effect, Drug Safety, and 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 - Pharmacovigilance Abbreviations
Evolution of Global Pharmacovigilance Systems
Advanced Adverse Event Detection Techniques
Expedited Reporting Timelines and Strategies in Pharmacovigilance
Aggregate Safety Reporting Best Practices
Signal Management Lifecycle
Real-World Evidence (RWE) in Signal Detection
Multinational Adverse Event Reporting Challenges
Mapping Global Regulatory Landscape
Drug Approval Pathways – Comparative Review
eCTD Regulatory Submissions
Orphan Drug Exclusivity Protection
Biologics Licensing Applications (BLA)
Generic Drug Approval Pathways (ANDA, RLD) - Global ANDA Regulatory Pathways
Medical Device Directive to MDR Transition
EU IVDR Essentials
Post-Approval Changes Regulation (Type IA, Type IB, and Type II)
Global Over-the-Counter (OTC) Regulatory Frameworks
Controlled Substances Regulatory Challenges
Global Pharmaceutical Law Landscape
Advanced Lifecycle Management
Drug and Device Combination Product Oversight
Advanced Practice of Pharmacovigilance
Additional Encompassing and Confusing Terms in Pharmacovigilance
MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
Need for Pharmacovigilance
The History of Pharmacovigilance
Roles in Pharmacovigilance
Key Stakeholders in Pharmacovigilance
Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)
Signal Detection (Detection, Validation, Prioritization, and Action)
Risk Assessment, Plan, and Management
Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)
Post-authorization/Post-marketing Regulations in Pharmacovigilance
Leading pharmacovigilance and regulatory affairs training with data-driven alumni success
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 MoreI 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.
Read LessI 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 MoreI 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 LessWell 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.
Read LessVery informative and easy to understand all slides and presenter.
Very informative and easy to understand all slides and presenter.
Read LessGreat and easy to go through.
Great and easy to go through.
Read LessVery thorough. Lots of references for EU & US
Very thorough. Lots of references for EU & US
Read LessEasy to read and follow along
Easy to read and follow along
Read LessIt was very informative and really useful training for PV professionals
It was very informative and really useful training for PV professionals
Read LessWould recommend for anyone interested in getting quality training in pharmacoviligance.
Would recommend for anyone interested in getting quality training in pharmacoviligance.
Read LessThe course is well organized and thoroughly taught. I love it!
The course is well organized and thoroughly taught. I love it!
Read Less
Take $100 Off For April Cohort using code tk100
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...
Read MoreI 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.
Read LessAs 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.
Read LessThis 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.
Read LessExcellent and detailed course
Excellent and detailed course
Read LessInformation 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.
Read LessThe text were legible and outlined the course.
The text were legible and outlined the course.
Read LessThe curriculum and video presentations are thorough and informative
The curriculum and video presentations are thorough and informative
Read LessVery good introductory PV course
Very good introductory PV course
Read LessI 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 MoreI 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 LessDetailed 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 LessTraining was good
Training was good
Read LessVery detailed, it covered all aspect of PV and Argus Safety Database
Very detailed, it covered all aspect of PV and Argus Safety Database
Read LessIt is a great review.
It is a great review.
Read Lessvery detailed and easy to understand. great learning tool
very detailed and easy to understand. great learning tool
Read LessQuite comprehensive.
Quite comprehensive.
Read LessExcellent and detailed course
Excellent and detailed course
Read LessI 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 MoreI 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 LessExcellent and detailed course
Excellent and detailed course
Read LessThe text were legible and outlined the course.
The text were legible and outlined the course.
Read LessIt is a great review.
It is a great review.
Read LessIt is a great review.
It is a great review.
Read LessVery detailed, it covered all aspect of PV and Argus Safety Database
Very detailed, it covered all aspect of PV and Argus Safety Database
Read LessGreat organization of material and easy to understand.
Great organization of material and easy to understand.
Read LessA
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
Read LessGlobalement 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...
Read MoreGlobalement 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.
Read LessThe 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 LessI 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 MoreI 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 LessI 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 MoreI 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 LessThe 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...
Read MoreThe 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.
Read Less“From CRA to Lead Safety Associate: "The course materials were clear, well-organized, and directly applicable to my work.” ”
“From International PV Roles To North American Market Success: “The detailed modules prepared me excellently for real-world applications.” ”
“From Physician to Confident Drug Safety Specialist: “The course provided a robust foundation in the field, which was critical for my professional development.””
Industry Transition: You’re a clinical, research, or regulatory professional ready to break into advanced PV/RA roles.
Expert Positioning: You have a medical or research background but need to stand out as a PV/RA expert.
Career Advancement: You’re already in PV/RA but crave better tools, structure, and promotion-ready skills.
Long-Term Growth: You’ve outgrown your current role and want sustainable, global career advancement.
Trusted Training: You need a comprehensive pharmacovigilance and regulatory training curriculum proven to get you ahead—just check our syllabus.
160+ Modules: Learn from over 160 role-specific modules tailored for top biopharma and CRO environments.
Hands-On Training: Get practical with real‑world case studies, protocol walkthroughs, and regulatory frameworks.
Proven Community: Join a network of 3K+ alumni, with many advancing into senior roles.
Accredited Excellence: Earn CPD & CME‑approved advanced training trusted by global employers.
Real Support: Enjoy lifetime access, 24/7 support, live webinars, mentorship, and a LinkedIn badge.
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.
In-Depth Advanced PV/RA Training Modules ($1299 Value). 50 Page APRAC Study Guide + Certification Exam Backed by CPD + CME Credits. Lifetime Access to Unmatched Curriculum.
+ 1-1 Mentorship
+ Career Accelerator
Our alumni are hired by top organizations across the globe, click to see more
Graduates work at: Novo Nordisk, Moderna, Abbott, Accenture, CVS, Walgreens, FDA, VA, GoodRx, Merck, NIH, MOH Ontario, Thermo Fisher Scientific, Procter & Gamble, AbbVie, Parexel, Regeneron, Bristol Myers Squibb, IQVIA, Memorial Sloan Kettering Cancer Center, NewYork-Presbyterian Hospital, Johns Hopkins Medicine, Tufts Medical Center, Beth Israel Deaconess, UF Health Cancer Center, MD Anderson, Emory Healthcare, Eli Lilly, L'Oréal, Northwestern Medicine, etc.
Our graduates quickly advance into high-impact roles, click to see more
Regulatory Affairs Associate, Clinical Trial Drug Safety Associate, Drug Safety Specialist, Patient Safety Senior Associate, Pharmacovigilance Scientist, Pharmacovigilance Manager, Senior Pharmacovigilance Associate, Pharmacovigilance Regional Head, Pharmacovigilance Analyst, Senior Director Quality, Pharmacovigilance Data Entry Manager, Principal Pharmacovigilance Scientist, QA & Medical Complaint Handling Associate, Senior Manager Medical Safety Officer, Medical Affairs Senior Scientist, Quality Manager, VP Medical Affairs, Clinical Guidelines Coordinator, Clinical Data Monitor, Pharmacovigilance Specialist, Regulatory Project Manager, Product Safety Manager, Manager Pharmacovigilance Operations, Regulatory Affairs Manager, Clinical Pharmacist Consultant, Product Vigilance Manager, Epidemiologist, Senior Manager Safety & Pharmacovigilance, Associate Director of Pharmacovigilance, QPPV, Pharmacovigilance Deputy, Regulatory Affairs Supervisor, Senior Scientist, Senior Medical Advisor, Cosmetovigilance, Drug Safety & Medical Information Specialist, Environmental Analyst, Vice President Clinical Development, Operation Specialist, Regulatory Affairs Supervisor & QPPV, Senior Director Clinical Operations, Vice President Operations, QA Executive, Health Advisor Pharmacist, COVID Health Specialist, Senior Project Manager, Pharmacy Manager, Trial & Supply Management, etc.
Master Pharmacovigilance & Regulatory Affairs in just 4 simple steps.
Choose your PV/RA enrollment tier: Operations Masterclass™ or Leadership Fellowship™. Gain instant access to all materials. Finance via Klarna, Affirm, or interest-free in-house plan (3×$500).
Access the entire curriculum immediately. Dive into modules at your own pace or follow a structured schedule. Our flexible platform is designed for busy professionals balancing work, life, and career development.
Complete interactive quizzes, real-world case studies, and practice scenarios. Track your progress effortlessly and revisit lessons anytime to reinforce your knowledge.
Earn your recognized PV/RA certificate upon completion. Showcase your specialized skills in pharmacovigilance and regulatory affairs, and step confidently into advanced career opportunities.
Thousands of alumni choose our CCRPS APRAC certification for its advanced curriculum that trains researchers at every level in senior skills for lifelong career success. That's why 1 in 5 quickly land managerial roles. Ready to start or advance your PV/RA career? See why our alumni choose us, risk-free.
14 Day Refund Policy
Unmatched Curriculum: 169 in-depth lessons—including 90+ new for 2025—taught by live expert instructors.
Top-Tier Career Outcomes: Alumni work at Novo Nordisk, Moderna, Abbott, FDA, MD Anderson, and more.
Mentorship & Fast-Track Learning: Personalized mentorship, on-the-go access, and live webinars.
Flexible Investment: Up to 3 months of payment plans and a 100% money-back guarantee.
Build an advanced foundation in global pharmacovigilance and regulatory frameworks.
Master safety database tools, specialized PV areas, and global regulatory strategies.
Advance your skills in regulatory submissions, strategic planning, and leadership.
Develop robust QA skills, access industry resources, and prepare for your certification exams.
This CPD-accredited certification is designed to help clinical, research, and regulatory professionals master drug safety, adverse event management, and global regulatory compliance. You’ll gain real-world skills aligned with ICH‑GCP, FDA, and EMA guidelines to excel in PV and RA roles.
The program features 169 advanced modules covering:
Yes, you can add GCP certification modules if needed. Our curriculum aligns with ICH GCP principles to ensure thorough compliance and readiness for regulatory audits.
This certification is ideal for clinical, research, and regulatory professionals—whether you are an IMG, MD, PhD, PharmD, or hold another advanced degree—seeking to transition into or advance in specialized PV/RA roles.
Yes. The course is accredited by recognized bodies (CPD and CME) and is trusted by industry employers globally, ensuring your certification is valued worldwide.
You’ll receive an Advanced Pharmacovigilance & Regulatory Affairs Certificate, complete with CPD/CME credits and a LinkedIn badge to showcase your expertise.
Most students complete the course within 4–6 weeks by dedicating 5–7 hours per day. However, you can learn at your own pace and revisit materials anytime with lifetime access.
Our advanced curriculum focuses on practical, real-world application. We offer personalized mentorship, interactive case studies, live seminars, and a proven track record of graduates stepping into senior PV/RA roles worldwide.
You’ll explore drug safety reporting, risk management, global regulatory guidelines, eCTD submissions, post-marketing surveillance, and more. Our curriculum is regularly updated to reflect the latest industry standards and regulations.
For professionals transitioning from advanced backgrounds (IMG, MD, PhD, PharmD, etc.), entry-level roles typically start at around $70,000 to $90,000. With experience, many professionals move into positions that pay between $100,000 and $160,000 annually, with senior roles such as PV Manager or QPPV exceeding $170,000 per year. Our certification has helped many achieve significant salary boosts and accelerated career growth.
All lessons are 100% online and self-paced, featuring interactive modules, live webinars, and downloadable resources. This flexible format lets you learn anywhere, anytime.
Students gain access to advanced resources such as Argus Safety training, AE/SAE logs, protocol deviation trackers, SOP samples, regulatory filing templates, and job search scripts to accelerate career growth.
Yes. You’ll complete a 50-question multiple-choice exam, requiring a minimum score of 70%. Two attempts are included, and most students pass on their first try.
Absolutely. Our flexible, self-paced modules are designed for full-time professionals. You can easily balance work, personal life, and study commitments.
Yes. Weekly live sessions offer group mentorship. Premium tiers include one-on-one coaching, personalized job search guidance, and advanced exam preparation to fast-track your success.
We offer a 14-day risk-free money-back guarantee. If the program doesn’t meet your expectations, you’ll receive a full refund—no questions asked.
We accept all major credit cards (Visa, MasterCard, American Express, Discover) as well as PayPal, Klarna, Affirm, and Afterpay, processed securely via Stripe. Payment plans are also available for added flexibility.
Yes. You can start with a standard or bootcamp package and upgrade anytime to unlock additional mentorship, advanced exam prep, and personalized career coaching.
Yes. Our career services include resume editing, LinkedIn optimization, interview prep, and networking guidance to connect you with top employers in pharmacovigilance and regulatory affairs.
A bachelor’s in science or equivalent (master’s, PharmD, etc.) is required. We provide all the fundamentals and advanced knowledge you need to succeed, regardless of prior PV experience.
You’ll be prepared for roles such as Drug Safety Associate, Clinical Trial Associate, Pharmacovigilance Manager, Regulatory Affairs Specialist, PV Scientist, and more. With additional experience, senior positions become attainable.
Yes. A 50-page downloadable study guide summarizes key concepts from all modules, helping you prepare for the final exam and serving as a quick reference on the job.
Over 10,000 professionals have completed CCRPS certification programs in CRC, CRA, and PV/RA since 2017, with many advancing into leadership roles at top pharma, CRO, and regulatory agencies.
Yes. Our modules meet IRB, CRO, and sponsor requirements for GCP documentation. You’ll earn a certificate and transcript to verify compliance for audits.
We offer the most advanced, application-focused curriculum with proven career outcomes. Graduates land higher-paying roles, benefit from real-world case studies, and gain continuous mentorship—making CCRPS a top choice for PV/RA success.
Adverse Events (AEs) are the building blocks of pharmacovigilance. They refer to any unwanted or harmful occurrences associated with the use of a drug.
Key AE Categories:What Happens to AE Data?
AEs are reported by healthcare professionals or patients and logged into Individual Case Safety Reports (ICSRs). This data is analyzed for patterns, contributing to decisions on drug safety measures. Mastering this component helps you identify AEs accurately, ensuring proper reporting and follow-up.
Signal detection is the process of identifying relationships between reported AEs and drugs. The goal is to highlight patterns that reveal safety concerns.
The Signal Lifecycle:This ensures that newly emerging risks are caught early.
PSURs are vital tools in post-marketing surveillance, summarizing safety data over time to ensure ongoing monitoring.
What is Included in PSURs?Every pharmaceutical manufacturer must submit PSURs (or PBRERs in some regions) periodically to regulatory agencies. This ensures accountability and transparency regarding drug safety.
Global collaboration is necessary for harmonized safety monitoring. Major players include the FDA, EMA, WHO, and MHRA.
How They Operate:These bodies function as watchdogs, ensuring companies comply with their safety commitments.
A Risk Management Plan (RMP) outlines strategies to minimize or handle AEs. It is a legal requirement in pharmacovigilance submissions.
Key Sections of an RMP:Understanding RMPs helps ensure a proactive approach to drug safety.
Drug safety heavily relies on maintaining and analyzing data in specialized databases.
Widely Used Tools:Learning these tools is critical to working effectively in pharmacovigilance departments.
Pharmacovigilance begins even before drugs hit the market.
Goals During Trials:Clinical trial safety ensures only promising drugs proceed to the next stages.
Quality assurance (QA) validates compliance across clinical, manufacturing, and post-marketing stages to minimize safety risks.
Common QA Practices:Strong QA systems are the foundation of good pharmacovigilance practices.
Effective communication is essential in pharmacovigilance for clear regulatory submissions and internal collaboration.
Key Skills:Understanding regulatory expectations ensures high-quality submissions.
Pharmacovigilance is an evolving field requiring constant updating of skills and knowledge.
Advanced Certification Options: