Director, Global Pharmacovigilance Operations Lead
Core
Oversee global pharmacovigilance (PV) case management activities for investigational and marketed products, leading strategic operational projects and initiatives.
Role type
Director, Global Pharmacovigilance Operations Lead
Builds
High-quality PV Individual Case Safety Reports (ICSRs), risk management documents, and safety reporting plans for regulatory filings.
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Global PV operations management, ICSR case management, risk management document development, vendor management, regulatory filing support, cross-functional collaboration, process improvement, team leadership, audit/inspection SME experience, Argus software proficiency, global PV regulations knowledge (FDA, EMA, ICH), MedDRA, drug development knowledge.
Preferred skills
Global experience, matrix leadership, project management, advanced biological sciences/healthcare administration degree.
Technologies
Argus, MS Office, MedDRA, EDC CRFs, Safety Gateway
Responsibilities
Lead PV operations for assigned products ensuring high ICSR quality control; oversee vendor case management activities including literature reviews, data entry, and case closure; provide operational support for risk management and document QC; conduct functional reviews of study protocols; manage discussions with license partners and develop PVAs; review EDC CRFs and Safety Gateway projects; lead creation of safety reporting plans and SOPs; execute PV activities for regulatory filings; collaborate cross-functionally with Clinical, Regulatory, QA, Medical, Manufacturing, Legal, and Commercial teams; lead weekly case review meetings; review product complaints; identify and implement continuous improvement opportunities.
Seniority
Director, strategic leadership with hands-on oversight