M1 Drug Safety Regulation and Good Pharmacovigilance Practices

Acquire a strong knowledge and a deep understanding of both local and global regulation and good pharmacovigilance practices which is the key to reach compliance and face challenges during audits and inspections.

Dr. Omar Aimer · January 25, 2021

Learning Path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)

What is Module 1?

As Drug safety is a highly regulated field, in this module, the pharmacovigilance trainee will acquire a strong knowledge and a deep understanding of both local and global regulation and good pharmacovigilance practices which are the key to reach compliance and face challenges during audits and inspections.

Why should I choose this course?

Would you like to join Pharmaceutical Industry and know more about Pharmacovigilance and Drug Safety job market?

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.

Why Drug Safety and Pharmacovigilance?

Increasing demand across the world for skilled professionals who can carry out surveillance safety trials and make reliable reports by leveraging the technological advancements in the field.

According to a new report by Grand View Research, Inc. released in January 2021, the global pharmacovigilance market size was valued at 6.33$ billion and expected to reach 14.95$ billion by 2028 with North America as the leading market for pharmacovigilance.

Who is this course for?

This Certification is designed for graduates who have a scientific background (MD, PharmD, nurses, BAC in science/biologic,…  aspiring to make a career in Pharmacovigilance/Drug Safety/Patient Safety.

Success Story

  • Success story of Pinak Joshi with his photo
  • Success story of Pinak Joshi and his background
  • Success story of Pinak Joshi and his struggle before joining the course
  • Success story of Pinak Joshi the struggle

This Course is brought to you by:

InnoVigilance logo

This Course is recommended by:

American Society of Pharmacovigilance logo

Do you have questions?

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
  • 6 Quizzes
  • Course Certificate

Ratings and Reviews

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What's your experience? We'd love to know!
Saly Dahab
Posted 1 week ago
Highly Recommended

This course so clear and proficient, I am really enjoying this course. It added much to my knowledge and motivated me to start a new career in drug safety.

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Fatima Abdallah
Posted 4 months ago
Highly recommended

This course so clear and proficient, I am really enjoying every bit of it. I believe it is really adding up to my knowledge and increasing my desire to have a specialty in this field.

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Pinak Joshi
Posted 5 months ago
Helped Me Get My First Pharma PV Job!

If you are even remotely interested in PV, this is hands down the best course you can get. The course materials are up-to-date, and every lecture is extremely important from a working job perspective. The things Dr. Aimer teaches here are the fundamental building blocks to your first steps in a PV career. Using what he teaches, I was able to perform well during my interview selection in a pharma c

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Katayoun Sabet
Posted 5 months ago
Very Well Organized

This course is well organized and clear. Provides a great base to build on. Highly recommended to anyone who is interested in PV.

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