M3 Safety Medical Writing, Quality and Compliance

Lead projects on identifying new potential risks and developing risk minimization action plan to prevent or mitigate these risks which are at the heart of all pharmacovigilance activities throughout the product lifecycle.

This module is part of the learning path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)

What is Module 3?

Once the pharmacovigilance trainee understands drug safety regulation and is able to handle PV activities on a daily basis, this module, allow him/her to lead projects on redacting Aggregate Reports and Risk Management Plans, identifying new potential risks and developing risk minimization measures, ensuring Quality and Compliance and contributing in Audits and Inspections.

About Instructor

Dr. Omar Aimer

Has over 10 years of experience focusing on Quality Assurance and Risk Management of Medical Devices in the hospital environment and more than 8 years in Pharmacovigilance. He has a Master of Pharmacovigilance and Drug Safety from Paris Descartes University with a strong knowledge of the European Medicine Agency's Pharmacovigilance Regulation and Good Pharmacovigilance Practices, and 5 years of experience in Pharmacovigilance in France (ANSM and Hospitals). Omar has 11 years of experience as a lecturer on Pharmacology in Algiers (Algeria) and Clinical Research in Versailles (France) and Organized Pharmacovigilance workshops in Montreal Canada. Since 2017, he works as a Pharmacovigilance Specialist Pharmaceutical Industry in Canada. Omar is an author and international speaker about the impact of Artificial Intelligence on Pharmacovigilance. He is currently leading projects for pharmacovigilance training and mentoring students at McGill University. In 2020, Omar earned a Certification on Improving Global Health Focusing on Quality and Safety from Harvard University. He is also an active member of the International and North American Society of Pharmacovigilance.

5 Courses

Not Enrolled

Course Includes

  • 5 Lessons
  • 5 Quizzes
  • Course Certificate

Ratings and Reviews

Avg. Rating
3 Ratings
What's your experience? We'd love to know!
Misbah Naveed
Posted 7 months ago
Awesome explanation

V, good and thorough insight of RMMS, PV audits and inspection and medical writing

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Arcelia Alvarez
Posted 1 year ago
Insightful info about risk management and audits/inspections

This module made me realize how important is to carry out PV activities beyond what I am used to do in a daily basis. I specially enjoyed the risk management lecture and I think the audit/inspection lecture has a very interesting outlook on how to ensure the quality of PV activities at all times, and what to expect before, during and after audits and inspections.

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Saly Dahab
Posted 2 years ago
Basis of Drug Safety

Thank you Dr. Omar for this great course. Being a medical doctor and starting a new career in PV, this course provided me with the basis of drug development and PV regulations across different countries.

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