Regulatory Affairs Assistant (safety/ pharmacovigilance)

Beijing Shanghai
Permanent
Full-time

1 day ago
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Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.Job Description1. 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

Bachelor's 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 InformationHow are we different?PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re 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 OpportunitiesPSI 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.

PSI CRO