Pharmacovigilance Coordinator (Japanese Skills Required)
Summary
Coordinates pharmacovigilance activities for clinical trials, processing safety reports and ensuring compliance with Japanese and global regulations using databases and Japanese-language medical literature.
We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.
In this role, you will provide day-to-day support to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials with the corresponding services. You will process and report safety information (including electronic reporting) throughout the course of the clinical trials. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals and investigational devices, collect relevant and reliable medical scientific information.
Permanent / Full-time / Office-based
The scope of responsibilities will include:
- 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
- A literature search conduction 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.
- 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
- Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus
- Organizational and planning skills
- Detail-oriented, able to multi-task and work in a fast-paced environment
- Communication and collaboration skills
- Proficiency in standard MS Office applications (Word, Excel and PowerPoint)
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.