Regulatory Affairs Assistant (safety/ pharmacovigilance)
Regulatory Affairs Assistant (safety/ pharmacovigilance)
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Job Description
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 :
- Bachelors or above degree in medical pharmacy and other life science related majors
- At least 1 year on relevant experience of regulatory or PV.
- Have knowledge of China regulation on PV
- Good communication and collaborative skills.
- Fluent in both oral and written English.
Additional Information :
How are we different
PSI is privately owned by the very people who founded the company more than 25 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.
Growth Opportunities
PSI is proud to invest in our people from entry-level team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
