Pharmacovigilance Coordinator
Summary
Coordinates pharmacovigilance activities for clinical trials, processing and reporting safety data to ensure patient care and regulatory compliance in Japan.
We are now 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.
Hybrid workstyle in either Tokyo or Osaka office
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.
- Non-medical review/triage of incoming safety reports
- Data entry of safety reports into the safety database
- 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.
- Communication with investigators regarding adherence to safety reporting rules
- College or University Degree (Biology, Bioscience or Pharmacy is preferred)
- Minimum of 2-3 years of prior experience in clinical or post-marketing research in similar role
- Administrative work experience
- Full working proficiency in Japanese and English
- Experience with safety databases and E2B reporting to Japan regulatory authority (PMDA) and other regulators is a plus
- Organizational and planning skills
- Detail-oriented, able to multi-task and work effectively in a fast-paced environment
- Good problem solving abilities
- Communication and collaboration skills
- Proficient use of 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.