Senior Director, EEA Deputy QPPV (m/f/d)
Core
Acts as the primary point of contact for pharmacovigilance oversight in the EEA, ensuring compliance with regulatory obligations and managing safety profiles for assigned products.
Role type
Senior Director, EEA Deputy Qualified Person for Pharmacovigilance (QPPV)
Builds
Pharmacovigilance system compliance and safety oversight for medicinal products in the EEA
Domain
Pharmaceutical Industry / Pharmacovigilance / Regulatory Science
Required skills
Pharmacovigilance regulatory expertise, PSUR/PBRER/RMP review, signal detection and assessment, regulatory authority communication, audit and inspection support, stakeholder management, SOP development
Preferred skills
Experience with PRAC activities, Medical Review Group participation, negotiation of scientific safety issues, leadership in safety forums
Technologies
ICH guidelines, CIOMS guidelines, RMP, PSUR, PBRER, DSUR
Responsibilities
Review and approve safety documents (PSURs, PBRERs, EU RMPs), provide scientific input to study protocols and reports, respond to regulatory authority requests, oversee pharmacovigilance system compliance, participate in PRAC and governance meetings, chair safety forums
Seniority
Senior Director, strategic leadership with hands-on technical oversight