UNIT 15: Vendor Oversight and Outsourcing in Pharmacovigilance
This unit explains how pharmacovigilance activities are outsourced to external vendors and how Marketing Authorization Holders retain regulatory responsibility through effective vendor oversight. It focuses on practical governance, contractual controls, performance monitoring, and compliance expectations in real-world PV operations.
Outsourcing in pharmacovigilance refers to the delegation of specific PV activities to external organizations such as Contract Research Organizations (CROs) or service providers. Companies outsource PV functions to manage workload, access specialized expertise, support global operations, and ensure scalability while maintaining regulatory compliance.
Key Points
Common practice in global PV operations.
Supports scalability and operational efficiency.
Does not transfer regulatory responsibility.
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