Overview of drug safety and pharmacovigilance basic notions, terminology regulation and main pharmacovigilance activities.
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.
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).
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.
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