Pharmacovigilance Coordinator (Japanese Skills Required)

About the role

PSI, a Contract Research Organization with more than 30 years of experience, is looking for a Pharmacovigilance Coordinator to support its global Pharmacovigilance Department and the In-Country Clinical Caretaker (ICCC) in clinical trials. The role provides day-to-day support and processes and reports safety information, including electronic reporting, throughout the trials.

Key responsibilities

• Serve as contact point for the Safety Desk and clinical project teams, ensuring safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) are received, distributed, documented and filed in a timely way.
• Enter safety reports into the safety database and perform non-medical review and triage of incoming reports.
• Control the quality of data entered in the safety database and distribute safety queries to sites and investigators.
• Maintain and update project-specific SAE distribution lists and SAE trackers.
• Conduct literature searches in a dedicated Japanese scientific database and triage articles.
• Maintain pharmacovigilance documentation and records so that all information stays up to date.

Required profile

• College or university degree; Biology, Biosciences or Pharmacy preferred.
• Full working proficiency in English and Japanese.
• At least 1 year of prior experience in clinical research (Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory specialist or Data Management Specialist) is a plus.
• Administrative work experience.
• Detail-oriented, able to multi-task in a fast-paced environment, with communication and collaboration skills.

Required skills

• Experience with safety databases and E2B reporting to regulators in Japan (PMDA) and others is a plus.
• Proficiency in standard MS Office applications (Word, Excel and PowerPoint).

What we offer

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