Global Medical Safety Lead

• Provide strategic medical safety leadership and practical contributions for assigned products
• Prepare safety contributions for global regulatory submission documents
• Perform safety signal management, benefit-risk assessments, and aggregate safety data reviews
• Lead cross-functional reviews of existing and emerging aggregate safety data
• Contribute to safety governance structures and activities
• Prepare and review safety sections of clinical and regulatory documents
• Support responses to regulatory authority inquiries
• Lead preparation of periodic safety reports and ensure their quality and consistency
• Oversee medical assessment of individual case safety reports
• Confirm criteria and content for expedited reporting and unblinding
• Lead or contribute to safety information prepared for Data Safety Monitoring Boards
• Provide medical safety contributions during internal audits and regulatory inspections
• Support updates to pharmacovigilance SOPs and controlled documents
• Support adverse event reporting training and pharmacovigilance awareness activities
• Support pharmacovigilance agreements with clinical development or commercial partners
• Participate in cross-functional teams and initiatives
• Report to the (Asset) Medical Safety Lead

• MD degree or equivalent required
• At least 7 years of relevant experience in the pharmaceutical/biotech industry
• At least 5 years of experience in pharmacovigilance/drug safety
• Experience in clinical practice or academic medicine is a plus
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
• Demonstrated ability to perform medical assessments of safety data from multiple sources
• Experience authoring complex documents and contributing to regulatory submissions
• Knowledge of adverse event reporting systems
• Strong scientific and analytic skills
• Excellent ability to interpret and communicate medical safety data from various sources
• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
• Excellent presentation skills and ability to communicate complex issues clearly
• Proficiency with Microsoft Office
• Fluency in written and spoken English
• Candidates must be located in Belgium, Switzerland, or the US (EST time zone)

• Short-term and long-term incentives program
• Equal consideration for employment without discrimination
• Inclusive work environment
• Locally applicable annual base salary hiring range shared during the recruitment process