Director Clinical Safety
Job Title : Director Clinical Safety
Job Schedule : Preference to have a local candidate who is based in tri-state and able to come into the office.
Responsibilities :
Incumbent will be responsible for responses to Health Authority inquiries on safety issues and prepares safety data for health authority review boards
Present safety data in SMTs as a recognized product safety expert and serve as the CSPV functional rep at Global multifunctional project team meetings
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 staff to assess new signals / risks emerging from post marketing data
This position may review and approve safety documents
Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active development, submission phase and during marketing phase
Safety Expert Overall : Serves as the physician responsible for safety profile and for leading SMTs for post marketing safety data from assigned products
Defines the risk component of the B / R assessment
Safety Expert Signal Evaluation : Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets
Safety Expert Risk Mitigation & Communication : Supports manager in recommending and implementing risk mitigation activities
Proposes risk mitigation solutions to management and SMT
Reports and Submissions : Contributes to and reviews safety sections of the NDA, CSR, and IB
years of Pharmacovigilance (PV) / drug safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work
Demonstrated ability to prioritize work, implement strategy and processes, collaborate with others
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