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Director Clinical Safety

Basking Ridge, NJ 07920

Posted: 04/08/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600701 Is job remote?: No Country: United States

Job Description

  • 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
  • 3-5 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

  • MD Degree Required
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