Global Patient Safety & PV Physician – Cardio‑Renal‑Metabolism

About the role

This senior position leads global patient safety and pharmacovigilance (PV) initiatives for cardio‑renal‑metabolism compounds across late‑stage development and post‑marketing. The role works closely with clinical development, medical affairs and global epidemiology to ensure a patient‑centric benefit‑risk approach.

Key responsibilities

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

Required profile

• Medical degree with clinical and/or research experience in cardio‑renal‑metabolism.
• Strong knowledge of patient‑safety strategies and PV regulations in major markets.
• Experience in clinical development and regulatory submission processes.
• Excellent medical‑scientific understanding of the therapeutic area.
• Strong interpersonal, communication and ethical standards.
• Fluent written and spoken English.

Required skills

• Pharmacovigilance (PV) processes and databases.
• Risk‑management planning and execution.
• Regulatory submission preparation (PSUR, DSUR, RMP).
• Benefit‑risk assessment and reporting.
• Clinical safety data analysis.
• Cross‑functional collaboration.

What we offer

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