Global Medical Safety Lead

Job Summary

Leading the assessment of medical safety data for assigned products, the full-time Global Medical Safety Lead will develop safety signaling strategies, collaborate with internal and external stakeholders, and ensure the safe use of products while working remotely or from locations in Belgium, Switzerland, or the US.

Key responsibilities

• Provide strategic medical safety leadership and conduct safety signal management and benefit-risk assessments for assigned products
• Collaborate with cross-functional teams to review existing and emerging aggregate safety data and prepare safety sections of regulatory documents
• Oversee the preparation of periodic safety reports and ensure timely, complete, and accurate safety information for regulatory inquiries

Required qualifications

• MD degree or equivalent required
• At least 15 years of relevant experience in the pharmaceutical/biotech industry, with a minimum of 5 years in pharmacovigilance/drug safety
• At least 1 year of experience in clinical practice or academic medicine
• Working knowledge of pharmacovigilance regulatory requirements and guidance documents
• Experience with authoring complex documents and contributing to regulatory submissions