Pharmacovigilance Certification

Advanced Pharmacovigilance & Argus Safety Certification (APVASC)

ACCRE Accredited I 180 Hours I Online I Instant Enrollment I Global Pharmacovigilance Training I Dual Pharmacovigilance & Argus Safety Certification I 1+ Week Completion/Certification I Tuition with 2-4 Month Payment Plans
Pharmacovigilance Certification
  • 2

    Advanced Review of Pharmacovigilance

    • Advanced Practice of Pharmacovigilance

    • Pharmacovigilance Quiz

    • Additional Encompassing and Confusing Terms in Pharmacovigilance

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

    • Pharmacovigilance Quiz

    • Need for Pharmacovigilance

    • The History of Pharmacovigilance

      FREE PREVIEW
    • Roles in Pharmacovigilance

    • Pharmacovigilance Quiz

    • Key Stakeholders in Pharmacovigilance

    • Pharmacovigilance Quiz

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

    • Pharmacovigilance Quiz

    • Signal Detection (Detection, Validation, Prioritization, and Action)

    • Pharmacovigilance Quiz

    • Risk Assessment, Plan, and Management

    • Pharmacovigilance Quiz

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

    • Post-authorization/Post-marketing Regulations in Pharmacovigilance

  • 3

    Argus Safety Database Certification

    • Argus Safety Database Certification Part 1 (Into and Video Demos)

    • Argus Safety Database Certification Part 2

    • Argus Safety Database Certification Part 3

    • Argus Safety Database Certification Part 4

    • Argus Safety Database Certification Part 5

    • Argus Safety Database Certification Part 6

    • Oracle Argus Safety User Guide

  • 4

    Resources

    • International Pharmacovigilance Initiatives and Guidelines - EMA

    • DIA Safety and Pharmacovigilance Competencies

    • Pharmacovigilance Career Resources

    • WHO-ISoP Pharmacovigilance Resources

    • E2E-Pharmacovigilance Planning

    • GVP XVI Addendum: Educational Materials

    • GVP Module I-IV PV Systems, PSMF, Inspections & Audits

    • GVP I: Pharmacovigilance Systems

    • GVP VIII: Post-authorisation Safety Studies

    • GVP III: Pharmacovigilance Inspections

    • GVP IX Addendum: Methodological aspects

    • GVP V: Risk management systems

    • GVP IX: Signal management-

    • GVP VIII Addendum: Requirements-recommendations_en-1

    • GVP XV: Safety Communication

    • GVP XVI: Risk-minimization measures

    • GVP II: Pharmacovigilance System Master File

    • GVP VI: Duplicate Management

    • GVI VI: Pharmacovigilance Audits

    • GVP X: Additional Monitoring

    • GVP VII: Periodic Safety Update Report

    • GVP VI: Collection, management, and submission of reports

Reviews

5 star rating

Pharmacovigilance training that is up to date with curren...

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...

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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

Required course by my employer - would take it on my own

Uchenna Akorah

This course was required training by my employer, a mid-size CRO. I found it to be interesting and much more engaging than the other CITI trainings we had to...

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This course was required training by my employer, a mid-size CRO. I found it to be interesting and much more engaging than the other CITI trainings we had to do.

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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

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 m...

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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.

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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 no...

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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

The only IAOCR-approved pharmacovigilance training

shama hussain

I was referred to this training from IAOCR. It is apparently the only approved pharmacovigilance program offered by them. IAOCR has a well-vetted approval pr...

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I was referred to this training from IAOCR. It is apparently the only approved pharmacovigilance program offered by them. IAOCR has a well-vetted approval program and you get a badge that signifies you are an IAOCR-certified pharmacovigilance professional after. Really solid course and good accreditation to back it up.

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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 ...

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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.

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5 star rating

Great for anyone in drug safety monitoring

Agustina Aguirre

Very interesting course, better done when working in the field of trials and with an ongoing project to carry out the experiences for. The course presents am...

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Very interesting course, better done when working in the field of trials and with an ongoing project to carry out the experiences for. The course presents amazing resources for us to use throughout our career. Even if your'e an expert, there is still something to gain from this course because of how it consolidates and presents the information we use on a day to day basis.

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5 star rating

Easiest way to learn pharmacovigilance

okechi nzedibe

This was one of the easiest ways to learn PV for me. I had bought a few books and watched videos on YouTube but found them to be dry and boring. Now I can re...

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This was one of the easiest ways to learn PV for me. I had bought a few books and watched videos on YouTube but found them to be dry and boring. Now I can really understand reporting and feel more equipped to work in the field.

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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 ...

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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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Enroll in our on-demand pharmacovigilance training online

Looking for professional pharmacovigilance training? If you hold an associate’s degree or higher and want to advance your career in Pharmacovigilance or want to increase your skillset with the Argus Safety Database, our diploma course in pharmacovigilance is right for you. Explore our in-depth 25-module course and complete it in as little as ten days to earn an accredited certification to boost your career.
Pharmacovigilance Roles

Document your dedication to your career with pharmacovigilance training & certification

Building your career could simply be a certification away. Safety and pharmacovigilance are essential activities that ensure the safety of patients. For stakeholders, regulators, and planning for pharmacovigilance activities optimizing the benefit-risk of evidence is critical. At CCRPS, we provide the knowledge that professionals need to meet regulations and requirements in an ever-evolving healthcare market. We have helped train thousands of professionals to achieve their Pharmacovigilance certifications. Whether you are a college graduate or a working professional, you can trust us to provide the in-depth training you need to advance your career in this competitive field.
Pharmacovigilance Roles

Pharmacovigilance Course Syllabus

What's inside our drug safety course?

Our pharmacovigilance training was designed by experienced pharmacovigilance officers. Using their knowledge and experience, they developed our course curriculum to give you advanced review of what you need to become a sought-after drug safety officer. Inside our course, you’ll find 25 in-depth modules that provide you the insights you need to become successful in pharmacovigilance and navigate around argus safety. If you’re on the search for a reliable pharmacovigilance training institute, you can trust the CCRPS drug safety training course.


Benefits of choosing our pharmacovigilance training

  • We Are Compliant: Our course meets WHO-ISoP and FDA guidelines. We are fully accredited by ACCRE and provide you with the quality training you need to be the best in the field.

  • On-Demand Learning Our courses are fully flexible and designed to be completed at your own pace. Work with your schedule, and avoid strict deadlines, all with our help.

  • International Accreditation: Once you complete our course, you will receive an accredited and globally accepted certificate valid up to 10 years after completion.

  • Advanced Review: Our course provides an advanced review of drug safety and argus safety database which can empower you to apply the knowledge you learn

  • Employment Prospects: Showing this advanced level of training improves your ability to interview well and get promoted within your organization


Pharmacovigilance Certification

The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse drug effects or any other medicine/vaccine related problem”[1]

A Qualified Person for Pharmacovigilance or QPPV plays a critical role in ensuring the safety of drugs, medical devices and other health-care products, through identification, evaluation, minimization and, where possible, prevention of Adverse Drug Events.

Pharmacovigilance is a modern science that has revolutionized the process of evaluating the safety and efficacy of drugs and other health-care products. The domain of pharmacovigilance is variously known as drug safety assessment (or simply drug safety) as well as regulatory affairs[2]

Extending beyond traditional approaches, modern pharmacovigilance does not limit drug safety assessment to isolated laboratory research or animal testing.  Instead, present-day  pharmacovigilance is data-driven[3]. It aims to establish the effectiveness as well as safety of health-care products through careful and detailed statistical analyses of data collected from large numbers of human patients (/ users).

Adverse Drug Events (ADEs) or Adverse Events (AEs): The Pivot of Pharmacovigilance (PV)

Title 21 of the Code of Federal Regulations (CFR) of the US Food and Drug Authority defines an ADE or AE as “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related”[4]. As outlined earlier, the overarching goal of PV is to maximize patient (/user) safety by minimizing or preventing AEs, in particular, Serious Adverse Events or SAEs.

To achieve this goal, modern PV follows the broad process outlined below:

Where no SAEs are identified during Phases I, II and III of clinical trials, PV conducts post-marketing surveillance through Phase IV of clinical trials. Here, PV involves collecting and monitoring patient (/user) outcomes from multiple hospitals and clinics, once an approved drug is publicly available.
Patient (/user) outcomes are carefully documented throughout Phases I, II and III of clinical trials during drug development, and all AEs are meticulously recorded, whether or not they appear to be related to the target drug. Phase IV or post-marketing surveillance data are once again subjected to careful analyses, in order to identify any previously unreported SAEs. QPPVs are required to notify the relevant regulatory authority (e.g., the FDA) of any SAE resulting from an approved drug.
Data on AEs is reported to the Clinical Research Organization (CRO) in charge of the clinical trials, where the frequency and severity of AEs are scrutinized and assessed.  The regulatory authority may then direct the pharma company to suspend or withdraw the drug; Based on the nature of the SAE and the drug, the pharma company (/ CRO) may be permitted to modify or directed to terminate the drug. 
In case of a Severe Adverse Event (SAE), a drug may be modified or even terminated by the CRO or affiliated pharmaceutical company.
A modified drug is subject to the same PV sequence as the original one.


The Growth of Pharmacovigilance (PV)

Pharmacovigilance, commonly abbreviated  ‘PV’, is a relatively new field. A series of medical tragedies in the mid-twentieth century, including the thalidomide[5] and chloramphenicol[6] catastrophes,  led the WHO to create the Adverse Drug Report or ADR database in the mid-1960’s. 

Today, the WHO Pharmacovigilance Programme includes 148 member countries[7]. In these countries, all new health-care products must meet stringent safety criteria developed by the respective regional or national regulatory authorities. Examples of such regulatory bodies include:

  • US Food and Drug Authority (FDA)

  • UK Medicines and Healthcare products Regulatory Agency (MHRA)

  • EU European Medicines Agency (EMA)

  • Japan Pharmaceuticals and Medical Devices Agency (PMDA)

  • China National Medical Products Administration (NMPA)
148+ Member Countries 

The rigorous, worldwide enforcement of safety standards has given rise to a burgeoning PV industry. Analysts Fortune Business Insights estimate the PV market worth at $6.28 billion in 2021, and project a CAGR of 13.1% over the next seven years, taking market size to $14.85 billion by 2028[8]. In the United States alone, the last 30 days saw 4,222 PV job openings being posted on the professional networking website LinkedIn[9].

Profile of a QPPV

The rapid growth of the PV sector has spawned a variety of job profiles for pharmacovigilance professionals or QPPVs. From its inception in the pharmaceutical industry, PV has now become an integral part of the business process in many sectors, including:

  • pharmaceutical manufacturers
  • health-care products manufacturers (e.g., biotechnology, medical devices)
  • cosmetics manufacturers
  • clinical research organizations or CROs
  • hospitals
  • government bodies and regulatory authorities (e.g., FDA and EMA)
  • business / knowledge process outsourcing companies (BPOs/ KPOs) specializing in health-care data analytics


PV positions range from entry-level positions for fresh graduates to senior management positions for veterans with years of industry experience. Naturally, jobs vary greatly in terms of required qualifications and expertise.

QPPV Personality Profile and Background Knowledge

Although QPPVs bring greatly different skills and qualifications to the table, they all possess a common set of qualities as well as competencies that helps them perform well in the demanding field of pharmacovigilance:


Effective Communication Skills: In the modern health-care set-up, PV forms an integral part of a complex network. PV operations often span multiple organizations, including the pharma company and/or CRO, as well as hospitals or clinics. Good verbal and written communication skills are thus critical to building a strong career as a QPPV.  Excellent verbal skills allow a QPPV to facilitate smoother interactions, among team members, with clinical site staff, as well as with patients and regulatory officials. Likewise, a flair for writing is invaluable in compiling insightful data summaries and professional reports, which forms an essential part of a QPPV’s responsibilities.
Attention to Detail: When it comes to health-care, a small difference in description can make a big difference to diagnosis[10]. The same holds for documenting AEs in the course of drug safety assessment: For instance, entering ‘LUQ’ instead of ‘RUQ’ (left instead of right upper quadrant) in describing abdominal pain may shift the focus of investigation from the liver to the spleen[11]The ideal QPPV is therefore someone whose painstaking attention to detail minimizes errors in record-keeping, thus reducing the likelihood of misinterpretation of data. Comfort with Medical and Technical Jargon: Both health-care professionals as well as pharmaceutical researchers rely on a large vocabulary of complex medical and technical terms. Maintaining and tracking data on health-care outcomes requires a QPPV to be at ease while navigating the often challenging terminology of the field. 
Highly Organized: As previously outlined, present-day PV ensures quality control in health-care products by tracking large amounts of patient (/user) data for incidences of AEs. A successful QPPV must be able to keep track of and retrieve data from numerous sources–clinical sites, field studies and historical databases, in a timely and efficient manner. Advanced Computer Literacy: As PV focuses increasingly on tracking health-care data from multiple sources[12], it is not just desirable but essential for a competent QPPV to possess fairly advanced computing skills, including (but not necessarily limited to) database management, presentation software and basic cloud computing skills.






Professional Profiles in Pharmacovigilance

As stated earlier, QPPVs are equipped with a wide variety of qualifications. The following section (adapted from the New Scientist) outlines the spectrum of PV jobs and their corresponding requirements for professional qualifications[13]

PV Database / Administrative Support: Another set of junior positions in PV, these generally require specialist computing skills, such as expertise in database management or know-how of specific softwares or computing platforms.

PV Specialist / Scientist:  Considered more senior PV positions, these profiles require at minimum a master’s degree in life science, along with research experience, although some profiles might require a doctoral degree. Candidates with medical and/or nursing degrees with the requisite research experience often qualify, and may even be preferred for certain profiles.

PV Associate / Drug Safety Associate: These entry-level jobs in the PV field typically require a minimum of a bachelor’s degree in life science (biology, microbiology, biochemistry, biotechnology, pharmacy, pharmacology, and so on). Candidates possessing an associate degree and relevant experience may also be eligible for some positions.
PV Team Lead / Manager: Recruitments to these positions tend to be based more on experience than on professional qualifications, although a basic life science degree is typically a must. These positions require administrative and managerial skills that are usually gained only through experience in PV roles. 

PV Director / Head: The most senior positions in PV are usually occupied by individuals with advanced medical and/or doctoral degrees, combined with decades of industry experience.


Why Choose a Career in Pharmacovigilance?

The description above clearly shows that building a career in PV requires an ability to stay alert and focused, a methodical bent of mind, as well as moderate to advanced levels of knowledge of medical and research terminology, besides proficiency with computerized databases and analytics. Even if the above profile fits well with your own temperament and skill-set, you’d be well-advised in wanting to know more before opting for a career in pharmacovigilance.

To that end, here is a summary of the most important factors that motivate people to pursue PV careers:

Social Contribution – The ability to contribute to the safety and wellbeing of millions of people worldwide is a strong motivation for many QPPVs. Every year, PV is responsible for preventing AEs and SAEs that could have resulted from scores of drugs marketed the world over. 

To illustrate: In 2015, European QPPVs alerted the EMA to an outbreak of allergic reactions to gentamicin, a common antibiotic[14]. This enabled authorities to identify the culprit — a contaminated batch of the Active Pharmaceutical Ingredient (API). Thanks to active PV, the defective drug batch was withdrawn before it could cause widespread harm.


Growth Prospects – The career graph of a QPPV can be quite steep, progressing from an entry-level ‘associate’ position, all the way to senior roles in heading PV operations at regional, national and international levels. According to ‘comparably.com’, a transparent job compensation database based on user-volunteered information, senior QPPVs in the United States can earn as much as $140,000[18].

Financial Reward – Median salary estimates for a QPPV vary. Conservative sources like ‘salary.com’ put this number at $72,748[15]. According to reliable sources such as  ‘payscale.com’, this figure can jump up to $85,125 in as little as a year  (see graph below)[16], or climb even higher, with ‘talent.com’ estimating it at $91,338[17].

  • Payscale Salary in PV - Range 60-220k+ in Regulatory Affairs


Core Challenges in PV and the APVASC Advantage

As already outlined, forging a career in PV can be demanding. In addition to requiring diverse aptitudes and abilities to qualify, there is generally a steep learning curve in the early days on the job. Novice QPPVs often struggle with the huge amount of medical research terminology, medico-legal codes and regulations they must learn, as well as the need to master health-care database use and management. 

Challenge #1 – Medical Research Terminology

QPPVs need to be not just familiar, but proficient in using a plethora of terms specialized for health-care research. Being able to distinguish ‘analgesics’ from ‘non-steroidal anti-inflammatory drugs’ (NSAIDs), differentiate ‘off label use’ from ‘overdose’, and grasp the difference between a ‘DSUR’ and a ‘PSUR’ (development vs. periodic safety update report) are all part of the day-to-day job requirements of a QPPV. 


Challenge #2 – Medico-legal Codes and Regulations

Compliance with regulatory requirements is a critical responsibility of PV. As such, every QPPV must be familiar with the relevant regional and national regulatory codes and laws. 

Thus, QPPVs in the United States must have a working familiarity with Title 21 of the FDA’s CFR[20]. In particular, QPPVs must be conversant with important sections such as Part 11 pertaining to Electronic Records and Electronic Signatures (ERES) requirements, as well as Code 355, outlining the Risk Evaluation and Mitigation Strategies (REMS) for drug safety assessments.

Similarly, QPPVs working in Europe must be familiar with Annex 11 of the code of Good Manufacturing Practice (GMP)[21], while in the United Kingdom, QPPVs need to acquire a working knowledge of the regulations for Clinical Trial Applications (CTAs) for Investigational Medical Products (IMPs)[22].


Challenge #3 – Health-care Software Use and Management

Tracking the effects of a drug across thousands of patients (/users) is a central part of modern PV, making it essential to maintain large databases of case information from multiple clinical sites. A number of software applications have evolved in recent years to facilitate PV processes. The most widely used are:

  •  Oracle Argus Safety
  • ARISg/ Lifesphere Safety
  • PvNET by Sarjen
  • Clinevo Safety

Using these software applications, QPPVs can monitor not only individual case details, but also generate and share information about patterns of AEs with authorized individuals and teams. Softwares such as Argus Safety additionally have advanced features that facilitate compliance; for example, Argus allows QPPVs to enter regulatory requirements into a database, such that the software can then automatically flag novel AEs that must be reported.



The APVASC Program for Pharmacovigilance Certification

Although careers in PV are open to graduates with life-science degrees, recruiters often seek individuals with master’s degrees or field-specific degrees or diplomas in pharmacovigilance. This is mainly owing to the specialized medical and research knowledge required of most QPPVs.

Earning a pharmacovigilance degree or diploma can be expensive, with tuition alone costing upwards of $7,000 in 2022. An added deterrent is that full- or even part-time college or university courses have requirements such as term-papers and project reports that are difficult to schedule for working professionals.

In contrast, the APVASC bypasses time and cost constraints by offering students the opportunity to gain accredited PV qualifications at their own pace, in their own time, and at a fraction of the cost of full-time pharmacovigilance training programs. The APVASC or Advanced Pharmacovigilance and Argus Safety Certificate program equips trainees with the requisite knowledge and skills needed for launching a successful career in PV.

The table below provides an overview of APVASC focus areas, outlining how each contributes to building or enriching a career in pharmacovigilance.


APVASC Focus Area

Contribution to PV Career

Drug Life Cycle, Clinical Trial Phases and Post-marketing Surveillance

Familiarity with process and stages in drug safety assessment

Grasp of important concepts such as risk assessment, Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs) and Important Medical Events (IMEs)

PV Medical and Research Terminology, MedDRA

Ease and proficiency in using complex medical and research terminology, drug categories, dosage and safety warnings

Knowledge and skill in using and identifying key terminology to detect patterns and anomalies in case reports and AE reports

Adverse Events: Signal Management and Reporting

Know-how of drug-specific side effects, risk factors and classifications 

Competency in detecting, validating, prioritizing and reporting Adverse Events (AEs)

ICH-GCP, National and International Regulatory Codes and Requirements

Understanding of the fundamentals of human participant (patient/ user) safety in health-care

Introduction to regulatory bodies and codes (e.g., FDA-CFR, EMA-GMP Annex 11, etc.)

Oracle Argus Safety Software

Basics of Argus database for case creation, data updating and retrieval 

Intermediate Argus features including data exporting, AE data analytics and visualization (tables, graphs)

Advanced Argus features including regulatory code specification, permissions and cross-institutional access

PV Documentation: Case Summaries, Reports and Plans

Skill in narrative writing for reports (e.g., ICSRs) and plans (e.g., Risk Management Plans or RMPs)

Aggregate reporting: compiling and condensing data summaries for DSURs, PSURs, etc.


APVASC Program Advantages


Maybe you’ve decided on a career in pharmacovigilance, but are unsure whether the APVASC program is right for you. Or, you’d simply like to be convinced of the powerful advantages offered by the APVASC program. In either case, the following list summarizes the many solid reasons why completing an accredited certification program such as the CCRPS’s APVASC is a great first step in a promising PV career:


  1. Argus Safety Certification built into the APVASC enables working PV professionals to upgrade their skills.

Although the APVASC is ideal for fresh graduates seeking to build a career in pharmacovigilance, this certification program also provides an ideal platform for experienced PV professionals seeking to improve their career prospects by building skills in health-care database use and management. Not only that, the APVASC’s focus on Argus Safety represents an industry advantage, since this is currently the most preferred, widely used PV software.


  1. CCRPS’s APVASC boasts solid accreditation and a 10-year validity.

APVASC is accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited by the American Medical Association (AMA), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC), and Interprofessional Continuing Education (IPCE). 


  1. APVASC is developed and taught by experienced QPPVs with years of industry experience.

This means that the APVASC certification gives you a real insider perspective on the processes and problems that pharmacovigilance professionals must cope with, as well as equip you with potential solutions and coping strategies.


  1. 100% of APVASC certification modules are online, and can be completed at your own pace.

The APVASC program is geared towards professionals and students who are juggling the demands of pharmacovigilance certification alongside with heavy work-loads. The 25-module APVASC program comprising 180 hours of courses is therefore available in a fully flexible, online format, which trainees can complete at their own pace. Where full-time study is possible, the certification program can be completed in as little as 10 days.


  1. The APVASC conforms to international health-care standards and is eligible to be considered for CME credits.

The APVASC course modules are designed in accordance with WHO guidelines, and meet the standards of the International Society of Pharmacovigilance (ISoP). Its high quality and multiple accreditations also qualify the modules of the program to be considered as Continuing Medical Education (CME) credits.


  1. The APVASC Focus Areas comprehensively cover all major knowledge and skill domains required for an entry-level QPPV.

As an APVASC-certified QPPV, you will have a working knowledge of not only medical and research processes and terminology, but also skill-sets in health-care software such as Argus Safety, as well as exposure to report compilation and narrative writing, thus smoothing your on-the-job learning curve and facilitating quick career growth.

  1. The updated APVASC certification course integrates PV training specific to vaccine development and delivery.

With the COVID-19 induced focus on global vaccination, the APVASC has been updated to incorporate pharmacovigilance mechanisms specialized for vaccine development and delivery. 

The global growth of pharmacovigilance as an essential business process within various industries, including pharmaceuticals, biotechnology and cosmetics represents an explosion in employment opportunities. However, the inherent challenges of a PV career mean that aspirants with an accredited skill-set and knowledge base have a distinct edge in terms of both recruitment and career progression. Now, you can gain that edge through the APVASC program.





References

  1. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/EMP_PV_Indicators_web_ready_v2.pdf
  2. Talbot JCC, Nilsson BS. 1998. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 45(5): 427–431. 10.1046/j.1365-2125.1998.00713.x
  3. Lavertu A, Vora B, Giacomini KM, Altman R, Rensi S. 2021. A new era in pharmacovigilance: Toward real-world data and digital monitoring. Clin. Pharmacol. Ther., 109: 1197-1202. DOI: doi.org/10.1002/cpt.2172
  4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32
  5. Vargesson N. 2015. Thalidomide‐induced teratogenesis: History and mechanisms. Birth Defects Res C Embryo Today. 105(2): 140–156. DOI: 10.1002/bdrc.21096
  6. Lietman PS. 1979. Chloramphenicol and the neonate--1979 view. Clin Perinatol. 6(1):151-62. PMID: 383361.
  7. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance
  8. https://www.fortunebusinessinsights.com/pharmacovigilance-pv-market-102746
  9. https://www.linkedin.com/jobs/pharmacovigilance-jobs?keywords=Pharmacovigilance&location=United%20States&locationId=&geoId=103644278&f_TPR=r2592000&position=1&pageNum=0
  10. https://wexnermedical.osu.edu/blog/how-and-why-to-describe-pain-accurately-to-your-doctor
  11. https://radiopaedia.org/articles/abdominal-surface-anatomy-2?lang=us
  12. Lee Ventola C. 2018. Big data and pharmacovigilance: Data mining for adverse drug events and interactions. P T. 43(6): 340–351. PMCID: PMC5969211.
  13. https://jobs.newscientist.com/en-au/article/getting-into-regulatory-affairs/?keywords=drug+safety
  14. Sardella M, Belcher G, Lungu C et al. Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance. Therapeutic Advances in Drug Safety. 16. DOI: 10.1177/20420986211038436
  15. https://www.salary.com/research/salary/posting/drug-safety-associate-salary
  16. https://www.payscale.com/research/US/Job=Drug_Safety_Specialist/Salary
  17. https://www.talent.com/salary?job=drug+safety+associate
  18. https://www.comparably.com/salaries/salaries-for-senior-pharmacovigilance-specialist
  19. https://www.meddra.org/training/schedule/1060/What%20is%20MedDRA%20and%20How%20is%20it%20Used%3F
  20. https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs
  21. https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/annex11_01-2011_en.pdf
  22. https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/annex11_01-2011_en.pdf



Frequently Asked Questions

If you have questions, we have the answers.

  • Who can I contact with questions or for help with the course?

    You can email us at SUPPORT@CCRPS.ORG! One of our experienced course representatives will get back to you within 1-2 business days.

  • How long is the course?

    The course is fully self paced and be completed in as little as 10 days.

  • Is this Certification Accredited?

    Yes! CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited by the American Medical Association (AMA), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC), and Interprofessional Continuing Education (IPCE) to provide CME credits for professionals.

  • What are the responsibilities of a Pharmacovigilance professional/Who would benefit from becoming one?

    Job descriptions may differ a little from posting to posting, but overall pharmacovigilance (PV) officers collect adverse event data on drugs (Phase 4) to analyze and change warnings for the drug. A minimum of an associate degree is required to take any training course including ours. Becoming a pharmacovigilance officer (PV) opens up a whole host of exciting and essential opportunities. These professionals collect adverse event data on drugs to analyze and change warnings for that drug.

  • Why take an online Pharmacovigilance Certification course?

    Generally, to qualify as a PV, you need a master's degree in pharmacovigilance. However, as this is both expensive and time-consuming, you can opt for our drug safety certification instead, which is fully recognized and enables you to land a job in the field.

  • What is the work lifestyle and salary of a Pharmacovigilance professional?

    After qualifying with CCRPS, you can apply for entry-level jobs such as Drug Safety Scientist, Safety Reviewer, Clinical Quality Specialist, Local Safety Officer, and more. Salaries for these positions vary, from a minimum of $67,000 for entry-level to around $136,000 for senior roles.