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).
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.