(Senior) Patient Safety Physician - Inflammation

The Position

Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you! Our dedicated Patient Safety teams are seeking experienced (Senior) Patient Safety Physicians to join us on our journey. You'll have the chance to work on a variety of products, either in clinical development or post-marketing drug safety. We're particularly interested in physicians with expertise in Inflammatory Diseases, Dermatology, Gastroenterology, Rheumatology or Pulmonology. If you're ready to take on this challenge and make a real difference in patient safety, we look forward to receiving your application!

Tasks & Responsibilities

• In this role as a (Senior) Associate Director / (Senior) Patient Safety Physician for Inflammation, you will lead or contribute to the global Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) activities for compounds in clinical development or in the market
• In more detail, your tasks may include: Developing/ contributing to proactive patient-centric RM strategies for assigned compounds; Planning, managing/ performing and monitoring all PV activities for assigned drugs, including: Set-up of safety analyses in the clinical trial and safety databases for monitoring
• In this role, you will continuously monitor and further develop the product safety and benefit/risk profile
• Managing safety issues will be one of your key responsibilities
• Collaborating with various departments, including Clinical Development and Global Patient Engagement, you will develop patient-centric benefit-risk profile assessment strategies for developmental compounds
• Together with Global Epidemiology and Medical Affairs, you will work on developing safety-focused post-authorisation studies
• Interpreting clinical trial safety data for clinical trial reports and submission documents will be part of your tasks
• You will provide medical-scientific input and review regulatory documents (e.g., PSURs, DSURs, RMPs, Clinical Overview Statements)
• As required, you will update senior management on the assigned drug’s safety profile and recommend PV/RM activities to BI decision-making bodies

Additional tasks for Senior Patient Safety Physician

• In this role, you will chair BI-internal multidisciplinary Asset Benefit Risk Teams
• Representing PSPV, you will participate in internal and external committees and bodies
• Staying informed about state-of-the-art methodologies, regulatory changes, and trends in the healthcare system and society, you will contribute to the further development of PSPV within BI

Requirements

• 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 would be an asset
• Clinical or research experience in one or more of the above disease areas would be a plus
• Good interpersonal and communication skills
• Strong ethical sense combined with quality and patient safety mindset
• Excellent English skills, both written and spoken

Additional Requirements For Senior Patient Safety Physician

• Profound experience in PSPV and Risk Management in a pharmaceutical company on a global / corporate level, including clinical development and post-marketing safety
• Very good and broad understanding of the pharmaceutical industry, and the future trends and developments in pharmacovigilance
• Thorough understanding of PV regulation in major markets and respective need for compliance
• Project Management competencies