Medical Safety Officer - PALM

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Product Safety

Product Safety Risk Management MD

Scientific/Technology

Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

The Medical Safety Officer (MSO) - Post Approval Lifecycle Management (PALM) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.

The MSO will report to the Portfolio Safety Head and oversee the safety assessment of assigned drugs within the 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 of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Portfolio Safety Head, 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.

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 Innovative Medicine products.

• 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.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
• Be an active partner and core contributor of safety input to key regulatory or clinical documents including:
  Risk management plans Safety development plan Clinical Trial Protocols Informed Consent Forms (ICF) Safety Sections of Investigator's Brochure (IB) and IB addenda Clinical Study Reports (CSR) Annual Safety Reports (ASR) Integrated Safety Summary (ISS) and Summary of Clinical Safety…