(Senior) Patient Safety Physician - Inflammation

As a (Senior) Associate Director / (Senior) Patient Safety Physician, you will lead or contribute to global pharmacovigilance and risk management for compounds in development or on the market. You work cross-functionally with Clinical Development and Global Patient Engagement to shape patient-centric safety strategies and post-authorisation studies. You monitor safety profiles, manage issues, and provide medical-scientific input for regulatory documents. You chair internal risk teams and represent PSPV in committees, driving development of safety practices. This role offers meaningful impact on patient health at scale within a leading biotech-pharma environment.

• Lead or contribute to global PSPV and RM activities for compounds in development or on the market
• Develop/provide proactive patient-centric RM strategies and oversee safety analyses in trials and safety databases
• Monitor and refine product safety and benefit/risk profile; manage safety issues
• Collaborate with Clinical Development and Global Patient Engagement to develop safety-focused assessment strategies
• Develop safety-focused post-authorisation studies with Global Epidemiology and Medical Affairs
• Interpret clinical trial safety data for reports and submissions; provide medical input for regulatory documents (PSURs, DSURs, RMPs, Clinical Overview Statements)
• Inform senior management on safety profile and advise on PV/RM activities for BI decision-making
• Chair BI-internal Asset Benefit Risk Teams; represent PSPV in internal and external committees
• Stay updated on regulatory changes and trends to advance PSPV capabilities within BI

• Medical Doctor with clinical and/or clinical research experience
• PV experience and good understanding of PV regulation in major markets
• Experience in Clinical Development and submissions for marketing authorisation is advantageous
• Clinical or research experience in inflammatory diseases is a plus
• Excellent interpersonal and communication skills
• Strong ethical sense with a focus on quality and patient safety
• Excellent English skills (written and spoken)
• Senior role: profound PSPV/RM experience in pharma on global level; broad industry understanding; PV regulation knowledge; project management competencies

• interpersonal and communication skills
• ethical mindset and attention to patient safety
• cross-functional collaboration
• pharmacovigilance (PV)
• risk management (RM)
• PSURs/DSURs/RMPs/Clinical Overview Statements