Company Description
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.
Job Description
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.
Qualifications
- 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)
Additional Information
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.
