1. 遵守企业现行批准生效的GMP、GVP文件，参与质量目标实现。

Comply with the current GMP and GVP documents approved by the company, and participate in the realization of quality goals.

2. 负责药品不良反应报告的收集、评价、处置与上报，管理和维护药品不良反应监测数据。

 Responsible for the collection, evaluation, disposal and reporting of adverse drug reaction reports, management and maintenance of adverse drug reaction monitoring data.

3. 负责文献检索，搜索网络文献数据库，了解我公司药品的安全性相关研究信息，对检索到的文献进行分析。

Literature search, search the network literature database, understand the research information related to the safety of our company's drugs, and analyze the retrieved literature.

4. 负责公司上市药品安全信号的识别、评估、风险确认，对确认的风险组织药品安全委员会开展风险评估制定风险控制措施。

 Responsible for the identification, evaluation, and risk confirmation of the company's listed drug safety signals, and organize the drug safety committee to carry out risk assessment and formulate risk control measures for the confirmed risks.

5. 负责药品上市后安全性研究项目的管理与跟进。

Responsible for the management and follow-up of post-market safety research projects

6. 负责定期安全性更新报告的撰写及提交。

Compile and submit Periodic Safety Update Report (PSUR).

7. 负责药物警戒年度报告的撰写及提交。

Compile and submit the Annual PV Report.

8. 负责解答公司药品安全信息咨询，指导安全用药。

Answer the company's drug safety information consultation, and guide safe drug use.

9. 负责药物警戒体系相关文件的起草及修订。

Draft and revise ADR management documents.

10. 负责药物警戒相关文件、记录和资料档案等的管理。

Responsible for archiving and management of pharmacovigilance related documents, records and archives.

11. 参加药品不良反应监测中心机构举办的相关培训班，了解本领域最新发展水平及政策法规。

Participate in relevant training courses organized by the Center for ADR monitoring to learn about the latest development level, policies and regulations in this field.

12. 对公司员工进行药品不良反应知识普及和相关法规培训。

Carry out ADR knowledge popularization and relevant regulation training among the staff of the company.

13. 领导安排的其他工作，包括注册、精益生产等方面的工作支持。