Medical Safety Officer - PALM in High Wycombe

Job Description

The Medical Safety Officer (MSO) – Post Approval Lifecycle Management (PALM) reports to the Global Medical Safety (GMS) organization. The MSO is accountable for assessing the medical safety of Innovative Medicine products and strategically leading cross‑functional matrix teams responsible for product safety and benefit‑risk oversight.

Essential Duties and Responsibilities

• Strategically lead the Safety Management Teams (SMT) for assigned products, overseeing safety surveillance (including signal detection) and risk‑management activities.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence clinical teams to minimize/mitigate patient impact by active participation in the design of clinical protocols.
• Partner and provide safety input to key regulatory or clinical documents, including:
  • Risk Management Plan (RMP)
  • 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 to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
• Actively participate in and contribute to meetings with Health Authorities and external key opinion leaders.
• Provide medical safety leadership on due diligence teams to evaluate licensing and acquisition opportunities.
• Provide medical oversight to contractors and non‑physician staff preparing written safety evaluations. Responsibilities include:
  • Defining the safety question or issue that requires medical safety assessment
  • Developing the strategy for the safety review and analysis
  • Interpreting results and determining the medical importance of the question or issue
  • Reviewing and approving (signatory) medical assessment reports (e.g., ad hoc safety reports)
• Work across GMS therapeutic areas to align and improve common processes, providing leadership and harmonized approaches to safety data collection, assessment, and safety‑related processes and issues.
• Assist in the review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools related to safety assessment and risk management.
• Lead or actively participate in department‑wide initiatives.
• Perform delegate responsibilities for other MSOs and/or SMT Chairs.

Minimum Qualification

• Physician (MD or equivalent) with 2–5 years of pharmacovigilance (PV) experience or related experience (e.g., clinical research, medical affairs, clinical).
• Board Certified, Board Eligible, or equivalent preferred.
• Medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Demonstrated knowledge of drug development principles, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development; global safety regulations highly preferred.
• Ability to influence, negotiate and communicate with internal and external stakeholders.
• Experience with Health Authority presentations preferred.

Required Technical Knowledge and Skills

• Ability to lead global cross‑functional teams effectively and strategically.
• Connect, collaborate and build consensus across relevant functions.
• Strategic thinking with global mindset, understanding implications to the business.
• Critically evaluate safety data from multiple sources (clinical trials, environmental studies, literature, etc.), assess clinical importance and potential strategic impact, and present findings clearly in written and oral communications.
• Experience and knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements in the US, EU, and globally; contributions to regulatory filings, PV documents, and risk management plans.
• Plan work to meet deadlines and handle multiple priorities.