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 regulation & Corporate； 确保上市后相关活动的工作时限满足法规及总部要求
Area of Responsibilities 主要职责：
- Work with the Sales/Marketing/Technical Service/BO team for complaint & AE handling (collection, evaluation, reporting in global SAP C3 system, investigation as appropriate, following up and closure); complaint process improvement; trend analysis; communication with manufacturing sitesfor complaint related issues.与销售 / 市场 / 技术服务 / BO 团队协作处理投诉及不良事件（包括信息收集，评估，在全球 SAP C3 系统中报告，视情况进行投诉跟进直至关闭；推动投诉流程持续改进；开展趋势分析；并就投诉相关问题与生产厂家进行沟通。 （40%）
- Be responsible for recall related activities implementation including leading the cross-functional team to implement all recall related activities, making sure all affected products are traced back and returned/destructed with evidence as requested by the authorities. 负责召回相关活动的执行，包括领导跨职能团队执行召回行动事宜，确保所有受影响产品均能被追溯，并按监管机构要求退回或销毁，且保留相应证据。（5%）
- Be responsible for PRER/Alert preparation. 负责定期风险评价报告及预警报告的准备。（10%）
2 QMS related 质量体系相关
- Document control and support internal and external audit； 文控及支持内外审核；
- All initial supplier/product/customer qualification related tasks, to meet GSP requirment 首营相关工作，满足GSP 要求
Area of Responsibilities 主要职责：
- Document control for QMS and Project Documents, including drafts, changes, review and comments, release, distribution, etc. Support internal and external audit. 负责质量体系（QMS）及项目文件的文档控制工作，包括编制、变更、意见汇总、发布、发放等环节； 支持内外部审计工作。（30%）
- All initial supplier/product/customer qualification related tasks, to meet GSP requirment 首营相关工作满足GSP 要求。（10%）
3 Other tasks per required 其他任务（根据具体要求） （5%）