Sr. Quality & Safety Manager
Novo Nordisk
- Shanghai
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Sr. Quality & Safety ManagerCategory: QualityLocation:Shanghai, Shanghai, CNKey responsibilities
- Maintains oversight of the management of safety information, safety risk management and all other pharmacovigilance (PV) activities in NNSH GSP for both Drug and Device.
- Ensure PV medical compliance (NN policies and standards, global and local regulation requirement) and inspection readiness.
- Design and execution of safety strategy and ensure high quality deliveries.
- Develop and implement safety related quality system.
- Independently perform proactive safety surveillance and risk management to effect product safety signal detection and evaluation, risk assessment and safety risk mitigating.
- Timely collecting and reporting AE from costumer to local HA AE system related NNSH.
- Analysis and evaluate AE trends, develop risk reduce plan.
- Monthly PV metrics/report calculation and preparation.
- Deviation identification and reporting to Head of GSP QA.
- Support data collection and preparation for MAH.
- Cooperate group level PV team to make sure NN internal compliance.
- Engagement in audit and inspection readiness and support as PV SME.
- Safety/PV related training material development and execute in NNSH GSP level.
- Drug &MD PV related regulation collection in China and Shanghai level.
- Regulation collection and analysis.
- Quality related document management support.
- Quality Audit support for NNSH GSP.
- Vendor, supplier, distributor quality management support.
- RDC quality oversight.
- AE related record management.
- Other duties as assigned by line manager.
- Bachelor degree or above in pharmacy, biology, chemistry, medicine or other related area
- Professional knowledge in local regulations.
- Problem solving ability and skills.
- Ability to face challenge and self-learning.