Pharmacovigilance Coordinator (Japanese Skills Required)

About the role

PSI, a leading Contract Research Organization, is seeking a proactive Pharmacovigilance Coordinator to support its global PV department and In‑country Clinical Caretaker (ICCC) on clinical trials. The role involves processing and reporting safety information, enhancing patient safety, and maintaining accurate pharmacovigilance documentation.

Key responsibilities

• Act as the primary contact for the Safety Desk and clinical project teams, ensuring timely receipt, distribution, documentation, and filing of safety reports (SAEs, RAEs).
• Enter safety reports into the safety database and perform non‑medical triage.
• Conduct quality control of database entries and distribute safety queries to sites/investigators.
• Maintain and update project‑specific SAE distribution lists and trackers.
• Perform literature searches in Japanese scientific databases and triage relevant articles.
• Keep pharmacovigilance documentation and records current and well‑organized.

Required profile

• University degree in Biology, Bioscience, Pharmacy or related field (preferred).
• Full professional proficiency in English and Japanese.
• Minimum 1 year experience in clinical research, clinical trial coordination, pharmacovigilance, regulatory affairs or data management.
• Experience with safety databases and E2B reporting to PMDA or other regulators is a plus.
• Strong organizational, planning and detail‑oriented abilities.
• Proficiency with MS Office (Word, Excel, PowerPoint).

Required skills

• MS Office (Word, Excel, PowerPoint)
• E2B safety reporting
• Safety database entry and quality control
• Japanese language (full working proficiency)
• English language (full working proficiency)

What we offer

• Flexible working conditions
• Extensive training and a collegial team environment
• Competitive salary and benefits
• Opportunities for personal and professional growth