Director, Medical Safety Officer: Immunology

Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Immunology to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.

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The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Janssen 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.

The MSO will report to the GMS Therapeutic Area Safety Head (TASH), Immunology and oversee the safety and benefit/risk assessment of assigned products within the Immunology TA that are marketed and/or in clinical development.

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 assessment of assigned products within the TA.

The MSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients.

In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.

Principle responsibilities include but not limit to the following:



* Strategically lead the Safety Management Teams (SMT) for assigned products.

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)


* Provide medical and scientific expertise as the GMS representative on the Compound Development Team (C...