Global Patient Safety & Pharmacovigilance Physician – Inflammation

About the role

This senior position leads global patient safety and pharmacovigilance (PV) initiatives for inflammation‑focused compounds across late‑stage development and post‑marketing. The role works closely with Clinical Development and other cross‑functional teams to ensure proactive risk management and regulatory compliance.

Key responsibilities

• Design and implement patient‑centric risk‑management strategies for assigned compounds.
• Oversee all PV activities, including database setup, continuous safety monitoring, and issue resolution.
• Collaborate with Clinical Development, Global Patient Engagement, Epidemiology, and Medical Affairs to conduct benefit‑risk assessments and safety‑focused post‑authorization studies.
• Analyze clinical trial safety data for inclusion in trial reports and regulatory submissions.
• Provide medical‑scientific input for regulatory documents such as PSURs, DSURs, RMPs, and Clinical Overview Statements.
• Chair multidisciplinary Benefit‑Risk Teams and keep senior management informed of safety profiles and recommended actions.

Required profile

• Medical degree with clinical and/or clinical‑research experience in the inflammation therapeutic area.
• Strong knowledge of patient‑safety strategies and PV regulations in major markets.
• Experience in clinical development and regulatory submissions is advantageous.
• Deep understanding of the pharmaceutical industry, emerging trends, and pharmacovigilance practices.
• Excellent English communication skills, both written and verbal.

Required skills

What we offer

• A highly strategic, development‑focused role with significant impact on new drug submissions.
• Opportunity to work in a global, intercultural environment.