Product Safety Manager

Department: MRQ (Medical, Regulatory and Quality)

Location: Beijing, China

The Position

• Support the PV operational processes and local PV compliance management, ensuring compliance with NN procedures and regulatory requirements:

- Act as a key partner who provides input, during the process of establishing local programs, comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of safety information. 
- Oversee safety in post-marketing programs, including but not limited to program assessment, training, PV qualification assessment of external partners, compliance check on external partners and project owners, PV agreements/SDEA review, coordination with Global Patient Safety etc.
- Develop and maintain local procedures to ensure compliance with NN procedures and regulatory requirements.

- Support PV audit/inspection readiness and prepare PV audits and HA insp...