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Global Safety Officer - MD

Edison-New Brunswick Metro Area, NJ

Post Date: 11/09/2017 Job ID: JN -112017-20403
MD, Board Certified/Board eligible, or equivalent, is preferred
  • Internal & External Safety Expert:
  • Provide PV and risk management expertise to internal and external customers and serve as Safety expert for assigned product
  • Maintain PV expertise, and understanding of international safety regulations and guidelines
  • Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
  • Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
  • Provide strategic and proactive safety input into development plans
  • Support due diligence activities and pharmacovigilance agreements I
  • Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
  • Management of product safety alerts
  • Responsible for signal detection and analysis Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group Identify and implement proactive safety analysis strategies to further define the safety profile.
  • Lead aggregate safety data review activities and coordinate safety surveillance activities for Signal detection and analysis
  • Development of safety action plans and implementation, as appropriate

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