Medical Safety Officer - PALM

Johnson Johnson; High Wycombe; On-site; GBP 120,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Medical Safety Officer (MSO) in Post Approval Lifecycle Management to lead safety oversight for assigned products. The role collaborates with GMS, clinical teams, and health authorities to ensure proactive safety assessments and risk management.

The MSO will report to the Portfolio Safety Head and guide safety strategy across therapeutic areas, ensuring compliant, timely safety reviews and risk mitigation for marketed or clinical-stage products.

Responsibilities

• Lead the Safety Management Teams (SMT) for assigned products, overseeing safety surveillance and risk management activities including RMP and REMS.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence other functions to minimize/mitigate patient impact by influencing clinical protocols.
• Contribute to regulatory and clinical documents such as Risk Management Plans, Safety Development Plans, Clinical Trial Protocols, CSR, PSUR, and SCS for NDA/BLA/MAA filings.
• Effectively communicate important results of medical safety and benefit/risk management evaluations to the GMS Leadership Team, CMO, and MSC.
• Actively participate in meetings with Health Authorities and external key opinion leaders.
• Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
• Oversee contractors and non-physician staff involved in preparing written safety evaluations, defining questions, strategies and interpreting results.
• Collaborate across GMS TAs to align and improve common processes with a harmonized approach across CLIs.

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

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

Job Description:

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.

Essential Job Duties and Responsibilities

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 (SCS) for NDA/BLA/MAA filings Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR) Health authority queries Core Data Sheets (CDS)
• Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
• Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.
• Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
• Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:
  • Defining the safety question or issue requiring medical safety assessment
  • Developing the strategy for the safety review and analysis
  • Interpreting results and determining the medical importance of a question or issue
  • Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports)
• Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across cli