Japan Licensed Pharmacovigilance Auditor
virtual vocationsDenver, CO
Japan Licensed Pharmacovigilance Auditor
Industries
Pharmaceutical Preparation ManufacturingOther Scientific and Technical Consulting ServicesOther Management Consulting ServicesAbout the role
Seeking a part-time Freelance Pharmacovigilance Auditor GVP GPSP, the successful candidate will plan and conduct risk-based audits and quality assessments in Japan, both onsite and remotely, while ensuring compliance with local regulations and client procedures.
Key responsibilities:
Plan and conduct risk-based PV/GVP/GPSP audits or quality assessments according to Japan's requirements
Review pre-audit documents and vendor arrangements, preparing audit agendas and evidence requests
Draft clear audit observations and reports, supporting debriefs and follow-up actions related to corrective measures
Required qualifications:
Hands-on experience in PV quality audit, GVP vendor/process audit, or GPSP/PMS self-inspection
Expertise in at least one specialist audit area and capability to assess evidence and identify gaps
Working knowledge of Japanese GVP and/or GPSP frameworks and PMDA/MHLW expectations
Native-level Japanese proficiency for detailed interviews and document reviews
Based in Japan, able to undertake onsite work and domestic travel as required
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JOB OVERVIEW
Experience level
Senior
Location
Denver, CO
Occupation
Compliance Officers
Industry
Pharmaceutical Preparation Manufacturing
Posted
yesterday
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