(Senior) Patient Safety Physician CRM

In this role you will lead and contribute to integrated patient safety and pharmacovigilance activities for compounds in development or on the market. You work closely with cross-functional teams to build patient-centric safety strategies and manage risk across the product lifecycle. You will interpret safety data, support regulatory submissions, and guide decision-making on safety activities. For the senior level, you lead governance and shape PSPV capabilities within BI, staying ahead of industry trends and regulatory changes.

• Lead or contribute to PSPV activities for compounds in development or on the market
• Design safety evidence generation strategies and proactive risk minimization plans
• Plan, manage, and monitor PV activities including safety analyses and benefit/risk monitoring
• Collaborate with Clinical Development and Global Patient Engagement to define safety-focused benefit-risk profiles
• Work with Global Epidemiology and Medical Affairs on post-authorization safety studies
• Interpret trial safety data for reports and regulatory documents (IBs, PSURs, DSURs, RMPs)
• Provide medical-scientific input to regulatory submissions
• Update senior management on safety profiles and recommend PV/RM activities
• Senior-specific: chair internal Asset Benefit Risk Teams and represent PSPV in committees
• Senior-specific: contribute to PSPV development through methodology and regulatory trend awareness

• Medical Doctor with clinical or clinical research experience
• PV experience and understanding of PV regulations in major markets
• Experience in clinical development and submissions for marketing authorization (asset)
• Clinical or research experience in cardio-renal-metabolism is a plus
• Strong interpersonal and communication skills
• Ethical mindset with strong patient safety focus
• Excellent English skills (written and spoken)
• Senior: extensive PSPV and Risk Management experience in pharma at global level
• Senior: broad understanding of pharmaceutical industry and PV regulatory landscape
• Senior: project management and leadership competencies

• Interpersonal and communication skills
• Team collaboration
• Ethical decision-making
• Pharmacovigilance (PV)
• Risk management
• Safety signal management