职位描述:

岗位职责

1.负责收集 、评估、处理和随访临床试验中 的 SAE 报告，并负责向研究者发送SAE 相关问询：

2.按照中国及其它地区法规要求及公司 SOP ，在时限内向监管部门进行个例报告快 速递交 ；

3.负责与相应部门进行 SAE 的定期一致性比对 ；

4.参与药物警戒团 队操作的标准化和流程优化：

5.参与 SMP 制定 ，参与 DSUR 等定期安全性报告的撰写，并参与支持 IND 、NDA中安全性相关文件的准备；

6.完成上级主管交代的其他工作 。

1 .Responsible for collecting, reviewing , and processing of SAEs repo11s from clinical trials, and responsible for sending SAE queries to investigators.

2.Responsible for expedited reporting to applicable regulatory authorities, accordance with China and other regions regulations and company Standard Operating Procedures .

3.Responsible for reconciliation of SAEs received from clinical trials with other functions. 4.Participate in standardizing and optimizing working procedures relevant to PV operation. 5.Participate in SMP preparation and DSUR preparation ; pai1icipate in safety related documents preparation in IND and NDA.

6.Finish the work assigned by the supervisor.

任职条件:

任职要求

1.医学、药学 、公共卫生、流行病学等相关专业 ，本科以上学历 ；

2.英文读写精通 ，熟练操作办公软件 ；

3.工作积极高效、有责任心和团队精神、并有较强的学习能力 。

1 .Medical, pharmacology, public health or epidemiology background, etc. and bachelor degree or above;

2.Excellent in English reading and writing, proficient in office software;

3.Work actively and efficiently, strong sense of responsibility and team spirit, and have strong learning ability.