Pharmacovigilance Physician Academy
Continuing Professional Development (CPD) for Pharmacovigilance Physicians
Certificate in Essentials of Pharmacovigilance Medical Review: open to individual physicians including those not currently working in Medical Review
Certificate of Added Qualifications (CAQ) in Pharmacovigilance Medical Review: limited to company sponsorship; intended to impact company practices
Certified Pharmacovigilance Physician: in development; currently closed to applicants
Certificate in Essentials of Pharmacovigilance Medical Review
open to individual physicians including those not currently working in Medical Review as well as to "new hires"
Part One: Training lectures
Pre-recorded videos:
1 Causality
2 PV Concepts: seriousness, severity, expected reaction, anticipated event
3 Immunological reactions to drugs
4 Drug induced liver injury (DILI)
5 Company Comment writing style
6 Drug safety and pharmacovigilance regulations
7 Introduction to MedDRA coding
8 Overview of Argus for Medical Review
Written exam: MedDRA coding using MedDRA Web-based Browser
You will receive a link to "TalentLMS," our Leaning Management System
Please complete at least one module per week.
"New hires" can complete Part 1 within two days.
Cost of Part One is $200 (US Dollars)
Part Two: Oracle Argus Safety Database
Complete Medical Review of 24 mock cases using a popular software system. Mock case types include spontaneous, Clinical Trial, and literature. There are four training modules which all must be completed within one month to avoid an additional fee. After completion of Part One, please pay the fee for Oracle Argus database access directly to our partner, ClinSkill. Also, login to our TalentLMS Learning Management System for additional training material.
Monthly live Q&A (optional)
Cost of Part Two is $399 (US dollars)
Please be sure to enter in the Order notes “American Society of Pharmacovigilance Physicians” so you will be assigned the 24 cases.
Part Three: Final Exam and Fee for Certificate
Oral exam: Company Comment, causality, and expectedness
Cost of Part Three is $99 (US dollars)
The Certificate in Essentials of Pharmacovigilance Medical Review does not grant CPD credits.
Both Part One AND Part Two are required to earn the Certificate.
Certificate of Added Qualifications in
Pharmacovigilance
Medical Review
Requirements:
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Open to physicians working in the Pharmaceutical Industry with a job that includes performing Medical Review of Individual Case Safety Reports (ICSRs). Currently your company must sponsor the program, which is intended to impact all Medical Review at the company.
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The CAQ is intended to demonstrate that a candidate has completed a formal education program covering advanced topics in pharmacovigilance medical review, as well as having submitted cases for formal review.
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Training supervised by a physician either at your company or by a consultant familiar with program standards.
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Certificate not valid for AMA PRA Category 1 Credit™ or AOA Category 1 credit.
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Information from the American Medical Association regarding Category 2 credit
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Certificate valid for 10 years. To renew for another 10 years, complete Maintenance of Certification (MOC) activities.
Head of Medical Review: Ask us how to become trained to offer this Certification to your team without cost. Small team? Ask us how to hire a consultant to assist you with content delivery.
Support provided by:
Certified Pharmacovigilance Physician
Pharmacovigilance Physicians provide medical guidance for signal detection and aggregate reports, develop Reference Safety Information, and have knowledge of medical review. Pharmacovigilance is based on epidemiology, the basic science of public health. This advanced Continuing Professional Development is intended to benefit "Global Safety Leaders."
Not currently accepting applicants
See above: Certificate in Essentials of Pharmacovigilance Medical Review
MedDRA Coding
Recommended face to face training offered by MedDRA* is listed at https://www.meddra.org/training/schedule
Coding with MedDRA (1 day, face-to-face)
MedDRA: Safety Data Analysis and SMQs (1 day, face-to-face)
*not affiliated with American Society of Pharmacovigilance Physicians