Job Description
Position Summary
The Pharmacovigilance Oversight Assistant Manager is responsible for providing operational oversight of pharmacovigilance activities performed by external service providers , primarily Contract Research Organizations (CROs) and vendors. This role ensures that all pharmacovigilance activities are conducted in compliance with global regulatory requirements, company procedures, and applicable safety agreements, maintaining the integrity and quality of the company’s safety data and reporting obligations.
Key Responsibilities
- CRO Oversight & Governance
- Serve as the primary point of contact for pharmacovigilance-related activities outsourced to CROs and vendors.
- Oversee the implementation and ongoing performance of pharmacovigilance service agreements and Safety Data Exchange Agreements (SDEAs).
- Monitor CRO performance metrics, compliance indicators, and quality deliverables.
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