Associate Marketed Project Safety Director - Sponsor Dedicated
Core
Deputy QPPV responsible for establishing and maintaining the pharmacovigilance system for marketed products in the EU/EEA, acting as a fully sponsor-dedicated role with delegated authority.
Role type
Senior IC pharmacovigilance director (deputy QPPV)
Builds
Pharmacovigilance systems and regulatory compliance for marketed pharmaceutical products
Domain
Life sciences / Pharmacovigilance / Regulatory Affairs
Required skills
Pharmacovigilance system management, RMP and risk minimisation measures, DHPC preparation, PSUR/PBRER review, PSMF maintenance, signal management, regulatory affairs (centralised and national procedures), health authority interactions, safety data interpretation, cross-functional collaboration
Preferred skills
Experience in Contract Research Organization (CRO) or Pharmaceutical industry, regulatory affairs across product lifecycle, independent decision-making, multi-project management
Technologies
None stated
Responsibilities
Assist QPPV in analyzing emerging regulations and their impact on pharmacovigilance processes, contribute to pharmacovigilance regulatory guidance, ensure PSMF accuracy, evaluate risks and communicate global impact issues, review and approve documents for regulatory submissions, manage product-related safety matters and benefit-risk assessments
Seniority
Senior, hands-on IC