工作内容：

1.    管理药物警戒相关标准操作规程(SOPs)/标准操作指导(SOIs)，及时确保其符合国家法规和公司内部规程。

Manage pharmacovigilance related Standard Operation Procedure (SOPs)/Standard Operation Instruction (SOIs) to ensure it is in line with national regulations and company internal procedures

on a timely basis.

2.    维护本地药物警戒体系主文件，并保持更新。

Maintain local PSMF and keep it updated as appropriate.

3.    制定药物警戒培训计划并及时实施，不断提高员工相关意识,

Make pharmacovigilance training plan and implement it timely to continuously improve employees' awareness.

4.    制定本地药物警戒活动质量控制计划并负责执行，如ICSR提交、PSUR/PBRER/DSUR提交等。

Make quality control plan of local pharmacovigilance activities and perform it, such as ICSR submission, PSUR/PBRER/DSUR submission etc.

5.    管理药物警戒活动相关各类协议/合同，确保其符合国家法规和公司内部规程的药物警戒要求。

Manage all kinds of agreements/contracts related with pharmacovigilance activities to ensure they meet the pharmacovigilance requirements of local regulations and the company's internal procedures.

6.     监测本地药物警戒相关法规，评估影响，必要时制定相应的行动计划

Monitoring of local pharmacovigilance regulation，analysis the impact and make action plan accordingly.

7.     主导/协调药物警戒体系稽查/检查的准备，并支持其他药物警戒相关稽查/检查。

Lead/coordinate the preparation of pharmacovigilance system audit/inspection, and support other

pharmacovigilance related audits/inspections

8.   执行直线经理分配的其他药物警戒活动的任务。

Implement other pharmacovigilance activities responsibilities assigned by LM.

任职资历：

1.     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 or master’s degree

2.      至少5年药物警戒/药物安全的制药行业经验

At least 5years of pharmacovigilance/drug safety related experiences in pharmaceutical industry

3.      了解国家和国际药物警戒法规的最新知识

Advanced knowledge of national and international regulations for pharmacovigilance

4.     良好的团队管理能力

Good leadership

5.      良好的沟通能力和项目管理能力

Good communication skills and project management skills

6.      注重细节，以任务为导向

Detail-minded and task-oriented person

7.      能够以中文和英语进行口头和书面交流

Ability to communicate orally and in writing in the local language and English