(Senior-) Director Head of Medical Review (Pharmacovigilance)

Role: Senior Director/Head of Medical Review (Pharmacovigilance) at BioNTech, overseeing safety assessments and process improvements for ICSRs in a global biotech setting. Responsibilities: lead a hybrid team of in-house and vendor medical review physicians; ensure high-quality assessments of critical cases such as SUSARs and immune-mediated events; develop SOPs and work instructions; drive continuous improvement in pharmacovigilance processes; collaborate with Medical Safety and Regulatory Affairs; manage vendor relationships, onboarding, and performance. Requirements: medical degree or advanced life sciences degree; 7–10 years in pharmacovigilance within biotech/pharma, preferably with oncology experience; leadership experience as Medical Review Lead or similar; thorough knowledge of global pharmacovigilance regulations (ICH, GVP); proficiency with safety databases like Veeva Vault; strong communication skills in English. HighValue: pharmacovigilance, ICSRs, SUSARs, immune-mediated events, pDILI, global regulatory compliance, vendor management, biotech/pharma, oncology, senior leadership. WorkSetup: global locations (US, UK, Germany), hybrid model.