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Senior Specialist Pharmacovigilance (Maternity Leave Cover)

BGR - Sofia City - Sofia (Nikola), BG💼 Full-time🗓 2026-09-11 → 2026-09-29

Core

Execute local pharmacovigilance operations, manage adverse event case processing, and ensure regulatory compliance for patient safety.

Role type

Senior IC pharmacovigilance specialist (maternity leave cover)

Builds

Safety data, regulatory reports, and compliance documentation for pharmaceutical products

Domain

Pharmaceutical industry + Drug Safety/Regulatory Compliance

Required skills

Adverse event reporting, PV regulations, Quality management systems, PV processes, Risk management plans, Literature screening, Health Authority monitoring

Preferred skills

Supervisory experience, PV audits, Health Authority inspections, Local language proficiency

Technologies

None explicitly stated

Responsibilities

Execute local PV processes and activities, Manage day-to-day adverse event processing, Support local PV agreements and due diligence, Prepare and submit Risk Management Plans, Support audits and inspection readiness, Coordinate aggregate safety report submissions

Seniority

Senior, hands-on IC with potential supervisory duties

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