Director of Pharmacovigilance Operations
7 days ago
Job Description
This role serves as the first point of contact for all safety-related issues for assigned compounds. The Global Patient Safety Lead leads the safety strategy, ensures optimal support, and collaborates with stakeholders to deliver the safety strategy.
Main Responsibilities
- Act as a resource for medical review for complex ICSRs and other data sources of assigned compounds
- Participate in the development and maintenance of relevant SOPs, working practices, and guides
- Cultivate cross-functional relationships and mentor junior safety scientists
Required Skills and Qualifications
- Able to apply and provide critical analysis of relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities
- Subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest
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