Medical Safety Officer - Immunology

About the role

The Medical Safety Officer (MSO) for Immunology will join Johnson & Johnson's Global Medical Safety organization. Reporting to the Therapeutic Area Safety Head, the MSO is responsible for the safety assessment of innovative medicine products throughout their lifecycle, from clinical development to market.

Key responsibilities

• Assess and characterize safety data for assigned drugs, ensuring proactive risk identification.
• Lead cross‑functional matrix teams and Safety Management Teams (SMT) to oversee safety surveillance, signal detection, and risk‑management activities.
• Develop and implement risk mitigation strategies, including Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS).
• Communicate potential and known risks to senior leadership, health authorities, prescribers, and patients.
• Provide medical and scientific expertise on Compound Development Teams and Clinical Teams.
• Anticipate safety concerns and influence related functions such as Clinical, Regulatory, and Commercial.

Required profile

• Medical degree (MD) with training or experience in medical safety/pharmacovigilance.
• Demonstrated experience leading safety assessments for marketed or investigational products.
• Strong understanding of regulatory requirements and risk‑management frameworks.
• Ability to work in a matrix environment and influence cross‑functional stakeholders.

Required skills

• Pharmacovigilance
• Risk Management Plan (RMP) development
• Risk Evaluation and Mitigation Strategy (REMS) implementation
• Signal detection and safety surveillance