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.

Dr. Omar Aimer · January 26, 2021

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.

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

  • 5 Lessons
  • 5 Quizzes
  • Course Certificate

Ratings and Reviews

Avg. Rating
1 Ratings
What's your experience? We'd love to know!
Saly Dahab
Posted 1 week 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.

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