Responsibilities
1. Ensures accurate and time-bound reporting of safety issues to China authorities, including but not limited to SUSAR, DSUR and other serious breaches.
2. Monitor national regulation changes on pharmacovigilance (PV) and update to management in a timely manner, to ensure all safety reporting activities in compliance with China PV requirements.
3. Routine review of China requirements on safety reporting.
4. Review project-specific Safety Management Plan, to ensure all safety reporting activities are covered.
5. Liaises with Regulatory Safety Reporting and PV units.
6. Support Regulatory Department for other tasks per needs.
Qualifications
1. Bachelor's or above degree in medical, pharmacy and other life science related majors
2. At least 1 year on relevant experience of regulatory or PV.
3. Have knowledge of China regulation on PV
4. Good communication and collaborative skills.
5. Fluent in both oral and written English.