Pharmacovigilance Associate II
Core
Coordinate crucial pharmacovigilance activities, manage a Book of Work of increased complexity, and mentor colleagues to support global drug development projects.
Role type
Senior IC pharmacovigilance associate (safety management)
Builds
Safety management plans, signal detection reports, meeting minutes, and regulatory responses
Domain
Life sciences / Pharmacovigilance
Required skills
Pharmacovigilance processes, Safety Management Team coordination, Signal detection, Medical safety assessment support, Project management, Regulatory inspection preparation
Preferred skills
Scientific technical skills, Data analysis and communication, Committee work experience
Technologies
SharePoint Online, OneSafe SMT (Veeva Vault SafetyDocs), Verity, EDC systems (TAO/RAVE)
Responsibilities
Support Medical Safety Assessment Physicians in leading cross-functional Safety Management Teams; Create meeting agendas and document decisions, timelines, and action items; Schedule Safety Data Review meetings and generate signal detection reports; Execute literature searches and Pharmacovigilance Agreement searches; Manage access, permissions, and content for SMT SharePoint and OneSafe SMT; Close safety-related health authority queries in Verity; Provide subject matter expert support and training for PV Associate processes.
Seniority
Mid-Senior, hands-on IC with mentorship responsibilities