(Senior) Patient Safety Physician – Cardio‑Renal‑Metabolism

About the role

We are seeking a Medical Doctor with a strong passion for patient health and safety to join our TA CRM team. The role focuses on patient safety and pharmacovigilance for cardiovascular, renal, hepatic, and metabolic disease programs, either in late‑stage clinical development or post‑marketing.

Key responsibilities

• Design and implement safety evidence generation strategies for assigned compounds.
• Develop proactive, patient‑centric risk‑minimisation plans.
• Plan, manage, and monitor pharmacovigilance activities, including safety analyses in clinical trial databases.
• Monitor and evolve product safety and benefit‑risk profiles, managing safety signals.
• Collaborate with Clinical Development, Global Patient Engagement, Epidemiology, and Medical Affairs on benefit‑risk assessments and post‑authorization studies.
• Interpret clinical trial safety data for reports and regulatory submissions.
• Provide medical‑scientific input to regulatory documents such as IBs, PSURs, DSURs, RMPs, and Clinical Overview Statements.
• Update senior management on safety profiles and recommend PV/RM actions.
• For senior candidates: chair internal multidisciplinary Asset Benefit Risk Teams and represent PSPV in internal and external committees.

Required profile

• Medical Doctor with clinical and/or clinical research experience.
• Experience in pharmacovigilance and familiarity with PV regulations in major markets.
• Background in clinical development and marketing‑authorisation submissions is a plus.
• Experience or interest in cardio‑renal‑metabolism therapeutic areas.
• Strong interpersonal, communication, and ethical standards.
• Excellent written and spoken English.

Required skills