Pharmacovigilance Coordinator (Japanese Skills Required)

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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.
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)

We offer:

Excellent and flexible working conditions

Extensive training and friendly, collegial team

Competitive salary and benefits package

Opportunities for personal and professional growth

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Originally posted on Himalayas