Pharmacovigilance Coordinator (Japanese Skills Required)

About the role

PSI, a leading Contract Research Organization, is seeking a proactive Pharmacovigilance Coordinator to support its global Pharmacovigilance Department and In‑country Clinical Caretaker (ICCC) on clinical trials. The role focuses on 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 review/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 up to date.

Required profile

• College or university degree (Biology, Bioscience, or Pharmacy preferred).
• Full professional proficiency in English and Japanese.
• Minimum 1 year experience in clinical research, clinical trial coordination, pharmacovigilance, regulatory affairs, or data management.
• Administrative experience and familiarity with safety databases and E2B reporting to the PMDA or other regulators is a plus.
• Strong organizational, planning, and detail‑oriented abilities; able to multitask in a fast‑paced environment.
• Effective communication and collaboration skills.

Required skills

• Proficiency with safety databases and E2B reporting.
• Advanced use of Microsoft Office applications (Word, Excel, PowerPoint).

What we offer

• Flexible working conditions and extensive training.
• Competitive salary and benefits package.
• Opportunities for personal and professional growth within a supportive, collegial team.