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Senior PV Associate

Sofia, Sofia City Province, bg💼 Full-time🗓 2026-09-22 → 2026-09-26

Core

Managing Individual Case Safety Reports (ICSRs) and safety data for pharmaceutical and biotechnology clients.

Role type

Senior Individual Contributor Pharmacovigilance Associate

Builds

Safety databases, regulatory reports, and monthly client deliverables

Domain

Life Sciences / Pharmacovigilance

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

ICSR processing, SAE/SUSAR management, MedDRA/WHO coding, data reconciliation, quality complaint handling, workflow management

Preferred skills

LCPPV/PRLS role execution, SOP adherence

Technologies

PrimeVigilance platform, MS Office

Responsibilities

Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, reconciliation), handling product quality complaints, generating database outputs and reports

Seniority

Senior, hands-on IC

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