岗位职责：

1. 支持/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。

Support/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. 支持/维护本地药物警戒体系主文件，并保持更新。

Support/Maintain local PSMF and keep it updated as appropriate.

3. 为相关外部和内部员工安排药物警戒培训，准备培训材料并维护培训文件。

Arrange pharmacovigilance training to relevant external and internal staffs, prepare the training materials and maintain the training documentation.

4. 支持/执行本地药物警戒活动质量控制，如ICSR提交、PSUR/PBRER/DSUR提交等。

Support/Perform quality control of local pharmacovigilance activities, such as ICSR submission, PSUR/PBRER/DSUR submission etc.

5. 为相关职能部门提供支持，确保与第三方签署的本地协议/合同符合国家法规和公司内部规程的药物警戒要求（如果预计第三方因其服务性质会接收不良事件报告）。

Provide support to relevant functions to ensure local agreements/contract with third party can meet the pharmacovigilance requirement of national regulations and company internal procedures if the third party is expected to receive adverse event reports due to the nature of their services.

6.   监测本地药物警戒相关法规。

Monitoring of local pharmacovigilance regulation.

7.   支持/参与稽查、检查。

Support/contribute to 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.

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3年药物警戒/药物安全/医疗事务相关的制药行业经验

At least 3 years of pharmacovigilance/drug safety/medical affair related experiences in pharmaceutical industry

3、能力要求 Competency

• 责任心强、态度认真，能合理安排工作，具有组织能力

Strong sense of responsibility and conscientiousness, priority setting, organizing

• 良好的沟通能力和项目管理能力

Good communication skills and project management skills

• 注重细节，以任务为导向

Detail-minded and task-oriented person

• 性格良好，具有团队精神

Good personalities with team spirit

4、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