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.