Medical Safety Officer - Immunology

About the role

The Medical Safety Officer (MSO) for Immunology is a physician responsible for the safety assessment of innovative medicine products throughout their lifecycle. Reporting to the Global Medical Safety organization, the MSO leads cross‑functional teams to ensure proactive evaluation of safety data and effective risk management.

Key responsibilities

• Assess medical safety of marketed and investigational immunology products.
• Lead Safety Management Teams (SMT) for signal detection, risk assessment, and implementation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS).
• Collaborate with Clinical, Development, and Regulatory functions to anticipate safety concerns.
• Communicate safety findings to senior leadership, health authorities, prescribers, and patients.
• Design and oversee risk mitigation strategies to ensure safe product use.

Required profile

• Medical degree with training or experience in medical safety/pharmacovigilance.
• Experience in product safety and benefit‑risk assessment for innovative medicines.
• Ability to lead matrixed, cross‑functional teams.
• Strong understanding of regulatory requirements and health‑authority interactions.

Required skills

• Medical safety assessment
• Pharmacovigilance signal detection
• Risk Management Plan development
• Risk Evaluation and Mitigation Strategy implementation