Associate Director, PV Document Management Oversight
Core
Lead the development and oversight of global aggregate safety reports (PSURs, NOAs) and risk management plans for investigational and marketed pharmaceutical products.
Role type
Senior individual contributor (IC) pharmacovigilance document management lead
Builds
High-quality periodic aggregate safety reports and risk management plans
Domain
Pharmaceutical industry / Pharmacovigilance
Required skills
Global regulatory compliance, aggregate safety report preparation, vendor management, team leadership, strategic oversight, cross-functional collaboration, CAPA implementation, safety data analysis
Preferred skills
Advanced degree in scientific/medical field, experience with epidemiology and clinical operations, knowledge of US/EU/international guidelines
Technologies
Word, Excel
Responsibilities
Provide leadership and mentorship to regional aggregate reporting teams; manage departmental budgets and resource planning; ensure compliance with global regulations for aggregate reports; collaborate with Global Safety Teams and functional areas; manage vendor relationships and quality; oversee functional specifications for data requirements; support audits and inspections; establish document working groups.
Seniority
Senior, hands-on IC with strategic oversight
