Drug Safety Specialist (Pharmacovigilance)

The Pharmacovigilance Specialist is responsible for delegated PV activities including intake with reconciliation and follow-up, individual case safety reports, aggregate submissions, compliance monitoring, local PV agreements, due diligence, audits, SOP authoring, training, and archiving, performed with minimal supervision. They may serve as backup local Qualified Person for PV (QPPV), Local PV Contact, or Responsible PV person per legislation. In the PV Lead's absence, they manage day-to-day PV activities.

Handles day-to-day adverse events case management, including intake, tracking, translation to English as applicable, acknowledgments, and follow-up per PV procedures and country regulations. Reports adverse experiences or product quality complaints associated with company products in compliance with Corporate Policy 01: Patient Safety. Coordinates translation of PV documents ensuring QC by a second person.

Serves as point of contact for local Health Authority for PV questions when assigned by PV Lead. Executes local PV processes in collaboration with internal functional areas and external parties. Supports PV audits, inspections, readiness activities, business partner audits, and CAPA development for findings.

Assists in developing and maintaining local procedures compliant with regional and global standards, evaluating for efficiency improvements. Supports PV self-inspections, training matrix, onboarding plans, and controlled documents. Participates in compliance monitoring and corrective actions for late reports.