岗位职责：
1.负责制定产品在中国的整体安全性策略、安全监测和风险管理，包括但不限于临床研究支持、上市后监测（如适用）、信号检测和管理、重要安全主题和监管提交。
Lead overall product safety strategy, specific areas of safety surveillance and risk management, including but not limited to clinical studies support, post-marketing surveillance (when applicable), signal detection and management, important safety topics, and regulatory submissions for assigned products.
1)审阅指定产品的安全性数据，进行信号检测，风险评估，制定相应的风险控制措施以进行风险管理，包括但不限于制定及维护本地风险管理计划等。
Review the safety data of assigned products, carry out signal detection and risk assessment, and formulate corresponding risk mitigation measures, including but not limited to formulating and maintaining local risk management plans, etc.
2)与临床研究团队合作，为相关监管活动（如新药研究申请，新药上市申请，上市许可申请等）提供药物安全方面的支持。
Collaborate with the clinical project team to provide clinical safety support for related regulatory activities, e.g., Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), etc.
3)准备各类安全性汇总报告（如PSUR/PBRER/DSUR等），确保高质量按照时限递交给监管部门。
Prepare various aggregate safety reports e.g., PSUR/PBRER/DSUR, etc. to ensure timely submission to HA with high quality of the documents.
4)管理来自内/外部利益相关方的药物安全的问询。
Address drug safety related queries from internal and external stakeholders.
5)为其他监管相关活动提供药物警戒支持，例如说明书审阅、再注册或来自监管当局的其他特殊要求。
Provide pharmacovigilance support for other regulatory related activities, e.g., PI review, license renewal, or other special requests from health authorities.
6)作为所负责的治疗领域的药物警戒专家参与各种项目，确保其满足药物警戒的要求，例如在以业务发展为目标的尽职调查中提供药物警戒建议。
Involve in various projects as pharmacovigilance expert for responsible therapeutic area to ensure they can meet pharmacovigilance requirement, such as pharmacovigilance input in due diligence for business development purpose.
2.在适当的情况下，作为地区CSPV代表加入所负责产品的全球注册递交团队，承担总部CSPV工作为总部CSPV团队做出贡献。
Join Global Submission team as regional CSPV representative for responsible products and contribute to global CSPV team by taking global roles, as appropriate.
3.及时向直接上级和全球产品安全负责人沟通潜在安全性问题或重要临床安全性信息。
Communicate the potential safety issue or important clinical safety information to line manager and global product safety lead timely.
4.支持药物警戒体系不断完善，如解读本地法规，分析差距，撰写/优化工作流程，实施培训等。
Support the continuous improvement of the pharmacovigilance system, e.g., interpret local regulation, conduct gap analysis, author/optimize working process, implement training, etc[MZ1.1][YY1.2].
5.参与稽查和检查。
Contribute to audit and inspection.
6.执行直线经理分配的其他药物警戒任务。
Implement other pharmacovigilance responsibilities assigned by LM.
资历要求：