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Executive / Senior Director, PV & Drug Safety - Medical Safety And Risk Management
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Full-time
- Job Overview: This job involves leadership in Drug Safety Pharmacovigilance, building and managing a Medical Safety and Risk Management team, overseeing safety and benefit-risk assessment of client's products, ensuring regulatory compliance, and collaborating with various departments in the organization.
- Build and manage Medical Safety and Risk Management team consisting of safety physicians and safety scientists.
- Responsible for signal management, risk management, and benefit-risk assessment of all products throughout the product lifecycle from First-In-Human to post-marketing.
- Provide strategic leadership in safety surveillance for clinical development programs and lead the safety perspective in NDA submissions.
- Review safety data of non-clinical studies to inform clinical development strategies and plans, including dose escalation protocols.
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