Medical Safety Officer – Post Approval Lifecycle Management

About the role

The Medical Safety Officer (MSO) – Post Approval Lifecycle Management (PALM) is a physician responsible for the safety oversight of innovative medicine products throughout their post‑approval lifecycle. Reporting to the Global Medical Safety organization, the MSO leads cross‑functional teams to assess safety data, manage risk, and ensure compliance with regulatory requirements.

Key responsibilities

• Assess and monitor the medical safety of assigned drugs in the therapeutic area, both marketed and in development.
• Lead Safety Management Teams (SMT) to conduct safety surveillance, signal detection, and risk‑management activities.
• Develop and implement Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) as needed.
• Communicate potential and known risks to senior leadership, health authorities, prescribers, and patients.
• Collaborate with cross‑functional stakeholders to ensure proactive safety assessments and timely risk mitigation.
• Represent Global Medical Safety on the Compound Development Team, providing medical and scientific expertise.

Required profile

• Medical degree (MD) with training or experience in medical safety/pharmacovigilance.
• Demonstrated ability to influence performance against company and division goals.
• Strong understanding of regulatory requirements and safety oversight processes.
• Excellent communication skills for interaction with senior management, health authorities, and external stakeholders.

Required skills

• Medical safety assessment
• Risk Management Plan (RMP) development
• Risk Evaluation and Mitigation Strategy (REMS) implementation
• Signal detection and safety surveillance
• Pharmacovigilance and regulatory compliance
• Cross‑functional team leadership