The primary objective of the Good Vigilance Practice (GVP) Specialist/Associate is, under supervision of GVP Manager, to facilitate GVP activities in cooperation with the QAQC group to ensure the appropriate implementation of safety measures in compliance with GVP ordinance and the overall effectiveness of GVP activities.
Principal Duties and Responsibilities
- Complaint Management (Registration, Reportability analysis, Investigation, Communication with Manufacture and submit investigation report to complaint customer)
- AE and FAE reporting to competent authority.
- Recall Management (Preparation of recall notification, Preparation for recall committee, oversight of progress of recall activities)
- Reviewing of PI and surgical technique in GVP aspects.
- Provide GVP training to sales reps.
Expected Areas of Competence (i.e. KSAs)
- More than 2 years of experience in PMS of class 3 or 4 implantable medical device.
- Engineering background such as mechanical engineering, electrical engineering, chemistry and so on.
- Good communication skill in English to communicate with foreign manufactures.
- Literature, MDR reporting experience is required
- Logical thinking, speaking, writing in both English and Japanese.
- Basic knowledge of Japanese PMDL is required.
Education/ Experience Requirements
Graduate from science course (Metal, Mechanical Engineering, Electrical Engineering, Chemistry)