M0 Pharmacovigilance Introduction and Basics

Overview of drug safety and pharmacovigilance basic notions, terminology regulation and main pharmacovigilance activities.

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

Why should I choose this course?

The course will be delivered by experienced trainers in the field who know the most critical aspects affecting PV employees firsthand. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach, our course will treat another different subject such as the international context of pharmacovigilance, and sources of information in pharmacovigilance, in order to document signal detection, ICSRs, PSURs, Referrals and more, presenting practical situations which may impact on daily activities.  We will also be talking about the latest updates national and international guidance (FDA, EMA,…) for signal detection in pharmacovigilance, with practical examples of medical evaluation in signal management, focusing also on the issues most frequently encountered.

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

  • 6 Lessons
  • 5 Quizzes
  • Course Certificate

Ratings and Reviews

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What's your experience? We'd love to know!
Ami Batavia
Posted 2 months ago
An overview of PV workflow with regulatory requirements.

Good lectures for an overview of whole process with details of regulations required. Lot of academic definitions and basics to refresh all your knowledge if you were away from work or have a gap for certain reason.

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Arcelia Alvarez
Posted 2 months ago
Useful info for a basic understanding of PV

The information presented is at the right level to launch your understanding of PV processes, and also to fill some gaps for information I did know in my experience.

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Olumayowa Dada
Posted 2 months ago
Good and easy-to-follow introduction to pharmacovigilance.

The introductory topic was well covered, but it focussed more on Canadian healthcare. Overall, I gained a lot from it.

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Saly Dahab
Posted 4 months ago
Job Readiness

This course is really unique as it prepared me for job interviews. Having Dr. Omar review my CV, provide feedback, assist with different questions that prepared me to go through job interview, as well as recommending me to recruiters. This is really a unique course. Thank you Dr. Omar

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