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Freelance Pharmacovigilance Auditor
ProPharma · Japan
Hybrid · Contract

+10K new in the last hour

Freelance Pharmacovigilance Auditor

ProPharma · Posted Nov 11, 2026

Japan
Hybrid
Contract

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Lead or co‑audit pharmacovigilance, GVP, GPSP projects across Japan, including on‑site and remote work.

Responsibilities

Plan and conduct risk‑based PV/GVP/GPSP audits
Review pre‑audit documents and safety records
Interview Japanese site, affiliate and vendor personnel
Draft evidence‑based audit observations and reports
Support audit debriefs and follow‑up actions

Requirements

Nice to have: Professional English
Nice to have: EU GVP
Nice to have: ICH E2
Nice to have: FDA safety‑reporting familiarity

Skills

Pharmacovigilance audit GVP vendor/process audit GPSP/PMS self‑inspection Japanese GVP framework PMDA/MHLW expectations CAPA effectiveness

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