【COMPANY OVERVIEW】
A leading precision oncology company focused on helping conquer cancer through the use of its proprietary blood tests, vast data sets and advanced analytics. Its products are designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.
【JOB RESPONSIBILITIES】
As the person in charge of safety management supervisor, the Safety (Senior) Specialist will carry out post-marketing safety management work based on the GVP.
Review safety information and discuss/implement safety measures.
Responsible for all aspects of processing (collection, assessment, reporting) of safety information.
Perform safety data analysis
Collaborate with internal stakeholder s to implement proper responsibilities and results when conducting safety procedures.
Report and respond to related regulatory authorities. (PMDA)
【REQUIREMENTS】
Qualified of safety management supervisor
At least 3year experience in medical device safety (GVP)
Post-marketing safety management experience
Experience working directly with the MHLW and other governmental agencies.
Native level Japanese and Business Level English
Understand start-up environment and can work as part of a team.
【FOR FURTHER INFORMATION】
Click apply
OR
Contact Saloni: