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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, focussing 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.
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).
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Are You Ready To Start?
- Pharmacovigilance department (organization, team, interactions) 01:00:00
- Case processing of ICSR (Individual Case Safety Report) 01:00:00
- Medical review and Causality Assessment and Reporting rules 01:00:00
- Drug Induced Adverse events 01:00:00
- MedDRA Coding 01:00:00
- Literature search and Social media 01:00:00
- Safety Databases training with a possibility of training in safety database 01:00:00
- PV recruitment readiness training videos 01:00:00
- PV CV/Resume 01:00:00
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