Pharmacovigilance Coordinator (Japanese Skills Required)
PSI CRO
•Remote
About The Position
PSI is seeking a knowledgeable and proactive Pharmacovigilance Coordinator to support the global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials. This role involves processing and reporting safety information, including electronic reporting, to enhance patient care and safety with novel pharmaceuticals and investigational devices. The coordinator will collect relevant medical scientific information and perform literature searches in a dedicated Japanese scientific database.
Requirements
- College or University Degree (Biology, Bioscience, or Pharmacy is preferred)
- Full working proficiency in English and Japanese
- At least 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory specialist, Data Management Specialist or the like will be a plus
- Administrative work experience
- Proficiency in standard MS Office applications (Word, Excel and PowerPoint)
Nice To Haves
- Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus
Responsibilities
- Serve as a contact point for Safety Desk and clinical project teams ensuring appropriate receipt, timely distribution, documentation, and filing of safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) reports.
- Data entry of safety reports into the safety database.
- Non-medical review/triage of incoming safety reports.
- Quality control of data entered in the safety database.
- Safety queries distribution to sites/investigators.
- Maintenance and timely update of the company’s project-specific SAEs distribution lists.
- Review and timely update of project-specific SAEs trackers maintained by PSI project teams.
- Conduct literature searches in a dedicated Japanese scientific database and article triage.
- Maintain pharmacovigilance documentation and associated records, ensuring all relevant information remains up to date and appropriately documented.
Benefits
- Excellent and flexible working conditions
- Extensive training
- Friendly, collegial team
- Competitive salary
- Benefits package
- Opportunities for personal and professional growth
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
