Medical Affairs 20229-MZ
Director Safety (MD)
Position leads SMTs (Signal Management Teams) and is a recognized product safety expert for assigned Phase 1 and 2a products. This position prepares, summarizes, and reviews aggregate safety analyses. Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III. This position performs safety assessments and determines the safety profiles of assigned products. This position also works with other CSPV (Pharmacovigilance) staff and SMT members and serves as the CSPV representative on TR-PT/IPT on Phase 1 and 2a products. This position may review and approve safety documents. Finally, this position also handles moderately complex safety matters, such as CSPV's preliminary proposal for safety monitoring in Phase 2 study with well-known AESI, with manager support.
Serves as the physician responsible for safety profile and for leading SMTs for assigned Phase 1 and 2a products. Defines the risk component of the B/R assessment. Has good working knowledge of regulations and guidance related to safety reporting and safety surveillance.
Performs more advanced aggregate signal identification activities formulated by manager.
Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets.
Supports manager in recommending and implementing risk mitigation activities. Proposes risk mitigation solutions to management and SMT.
Contributes to and reviews safety sections of the NDA, CSR, and IB. May first author white papers involving safety. Provides medical review for US and EU periodic reports. Co-owns RMP with manager.
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