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Director, Medical Safety Officer, Neuroscience And Ophthalmology
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Full-time
- Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Neuroscience and Ophthalmology, to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.
- The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Johnson & Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.
- Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients.
- SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS), as well as other activities related to managing the safety profile of assigned products (e.g., Program Safety Analysis Plan)
- Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings
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