M2 Pharmacovigilance and Drug Safety Operations

Handle basic steps in drug safety as day to day activities (Data collection, Data Entry in Safety database, Coding of adverse reaction descriptions, Case causality assessment and Timely reporting to authorities).

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

What is Module 2?

In this module, the Pharmacovigilance trainee will be able to handle basic steps in drug safety as day-to-day activities (Data collection,  Data Entry in Safety database, Coding of adverse reaction descriptions,  Case causality assessment and Timely reporting to authorities).

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

  • 7 Lessons
  • 7 Quizzes
  • Course Certificate

Ratings and Reviews

5.0
Avg. Rating
4 Ratings
5
4
4
0
3
0
2
0
1
0
What's your experience? We'd love to know!
Arcelia Alvarez
Posted 1 month ago
My favorite module so far

I enjoyed this module so much, it describes the PV operations thoroughly, specially the case processing and medical review lessons are key to understand the core of PV operations. It would have been nice to learn about unanticipated drug reactions, urgent safety measures, INDSRs vs SUSARs and analysis of similar events.

×
Preview Image
Pinak Joshi
Posted 8 months ago
Excellent course in a rich PV training course

I got my first PV position while completing the Silver Certificate course. Here with the Gold Certificate, it builds on this strong foundation, teaching the key mechanics and functions of pharmacovigilance with an international scope. This is key for any PV professional who is looking to enter and thrive in an increasingly competitive PV market.

×
Preview Image
Katayoun Sabet
Posted 8 months ago
Valuable Practical Training & Tips

This module got down to the nitty-gritty of pharmacovigilance, with great flow and organization. It increased my confidence level and clarified my vision towards my career goals. Thank you!

×
Preview Image
Saly Dahab
Posted 8 months ago
Excellent course which I enjoyed

It provided me with all the knowledge in PV field. Dr. Omar explained everything in a simple clear manner. It is an excellent course for anyone who wants to learn about PV and is in the process of a job search. All the tips Dr. Omar provided in the resume writing and the interview process are very helpful. Thank you, Dr. Omar.

×
Preview Image
Show more reviews
What's your experience? We'd love to know!