GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan
Job Summary
GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan.
Creating and submitting adverse event reports to PMDA and handling and assessing complaints and safety issues are key duties.
Collaborating with product assurance and post-market engineering teams in the US headquarters is required for obtaining investigation results and creating customer letters.
Matching Summary
GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan.
Skills & Requirements
Must-have
GVP activities
adverse event reporting
handling complaints
maintaining Japanese IFUs
document control GVP
Nice-to-have
business level English communication
knowledge of cardiovascular products
compliance management
continuous improvement
Key Requirements
Minimum 2 years GVP/post-market engineering experience