Japan Licensed Pharmacovigilance Auditor

Job Summary

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