岗位描述
岗位职责
This position is set up to take care of PMS related issues, such as complaint handling, AE handling, recall according to regulation/procedure requirement; take care of QMS related tasks and other tasks assigned by the line manager. 该岗位主要负责上市后监管(PMS)相关工作,包括依据法规/程序要求进行投诉、不良事件处理、执行召回;同时负责质量体系(QMS)相关任务以及直线经理交办的其他工作。
1 PMS related 上市后监管相关:
- implemented & improve PMS processes for both local products and imported products; 实施及优化现有进口及国产产品的上市后流程;
- Fulfil the PMS activities timeline requirement from r
岗位要求
1. BS degree or above in the following subjects: Medical Device, Pharmaceutics, Medicine, Chemistry, Biology and any other related subjects
2. Very good command of both spoken and written English
3. Very good command of MS office"
4. 2+ Quality experience in MD industry is required.
5. Comprehensive knowledge of GSP or GMP, AE reporting/evaluation ,recall and ISO13485 certified auditor is required.
6. Experience in PMS management and QMS is preferred. "
7. Excellent communication skills