UNIT 16: Practical Pharmacovigilance Operations and Cross-Functional Integration
This unit focuses on how Pharmacovigilance operates on a day-to-day basis within pharmaceutical organizations, translating regulatory requirements into practical workflows. It explains real operational responsibilities, cross-functional interactions, and decision-making scenarios encountered in routine PV practice.
Day-to-day pharmacovigilance operations involve continuous monitoring, processing, and evaluation of safety information received from multiple sources. These activities ensure that adverse events are captured, assessed, and reported within regulatory timelines while maintaining data quality and patient safety.
Key Points
Daily review of incoming safety information.
Time-sensitive case processing.
Continuous coordination with internal and external stakeholders.
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