Pharmacovigilance Coordinator (Japanese Skills Required)

About the role

We are seeking a proactive Pharmacovigilance Coordinator to support our global Pharmacovigilance Department and In‑country Clinical Caretaker (ICCC) on clinical trials. You will process and report safety information, help enhance patient care, and collect reliable medical scientific data throughout the study lifecycle.

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 such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs).
• Enter safety report data into the safety database and perform non‑medical triage of incoming reports.
• Conduct quality control of database entries and distribute safety queries to sites and investigators.
• Maintain and regularly 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 properly filed.

Required profile

• College or university degree (Biology, Bioscience or Pharmacy preferred).
• Full professional proficiency in English and Japanese.
• At least one year of 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 is a plus.
• Strong organizational, planning and detail‑oriented abilities, able to multitask in a fast‑paced environment.
• Effective communication and collaboration skills.
• Proficiency with Microsoft Word, Excel and PowerPoint.

Required skills

• Safety database usage
• E2B reporting
• Japanese scientific database literature search
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint

What we offer

• Opportunities for professional development in a people‑focused organization.
• A stable, innovative environment within a leading Contract Research Organization.