Edwards Lifesciences PMS Sr.Specialist in Tokyo, Japan
• Analyze medical records received from PMS (Post Marketing Surveillance) and produce annual report to PMDA. Identify and discuss data discrepancies and issues with Biostats and Data Management departments to develop solutions.
• Create submission for "reevaluation" by PMDA for final marketing approval
• Train hospital staff to enter data into hospital system and ensure data is input in a timely manner per regulations
• Recommend to PMDA and NCD (National Clinical Database) ways to improve data and address hospital and EW's concerns
• Provide guidance and direction to lower level staff
Experiences & Skills:
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.