具体职责：

1.审阅指定产品的安全性数据，持续有效地评估本地可用的安全性信息。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，如制定本地风险管理计划等。

Review the safety data of designated products, continuously and effectively evaluate local available safety information.

2.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，如制定本地风险管理计划等。

Carry out signal detection and risk assessment, and formulate corresponding risk control measures for risk management, such as formulating local risk management plan, etc.

3.审阅研究中的关键文件，如研究方案和CSR等，为研究提供药物安全方面的建议。

Provide safety input to clinical studies by reviewing study relevant documents such as study protocol and CSR, etc.

4.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.

5.管理来自内/外部利益相关方的药物安全的问询。

Management of drug safety related queries from internal and external stakeholders.

6.为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 regulatory related activities, e.g., PI review, license renewal, or other special requests from health authorities.

7.作为所负责的产品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，可以在以业务发展为目标的尽职调查中提供药物警戒建议。

Involved in various projects as pharmacovigilance expert for responsible products to ensure they can meet pharmacovigilance requirement, such as pharmacovigilance input in due diligence for business development purpose.

8.支持药物警戒体系不断完善，如撰写SOP，实施培训。

Support the continuous improvement of the pharmacovigilance system, e.g., SOP preparation, training implementation.

9.参与稽查和检查。

Contribute to audit and inspection.

10.执行直线经理分配的其他药物警戒任务。

Implement other safety responsibilities assigned by LM.

任职资历：

1.临床医学、药学、流行病学或相关背景，具有学士/硕士学位。

Medical, pharmaceutical, epidemiology or related background with bachelor/master’s degree

2.至少3-5年药物警戒/药物安全或医学事务相关的制药行业经验

At least 3-5 years relevant pharmaceutical industry experience in pharmacovigilance/drug safety or medical affair

3.英语书面和口语表达俱佳

Fluent in both written and spoken English

4.了解中国和国际药物警戒法规的最新知识

Advanced knowledge of national and international regulations for pharmacovigilance

良好的人际交往能力和多任务管理能力

Good interpersonal skills and multitasks management capability

性格良好，具有团队精神

Good personalities with team spirit

5.熟练使用计算机

Computer proficient