药物警戒医生

职位描述/Job Description：
1. 负责个例安全性报告（ICSR）的医学审阅，包括1）根据SOP要求审阅ICSR；2）评估ICSR的严重性、预期性和因果关系，并撰写公司评论；3）提出医学意见和质疑
Individual case safety report(ICSR) medical review, including: 1)Perform medical review of ICSR according to SOPs. 2) Assess seriousness,expectedness and causality of ICSR, and write company’s comments. 3)Provide medical advice and queries.
2. 负责上市前、后研究项目收集的安全性数据的监察和分析。
Perform safety data monitoring and analysis of pre or post-marketingstudy project.
3. 负责上市前、后研究项目相关安全性内容的审阅或撰写，如方案中的安全性相关部分，研究手册（IB）中的安全性相关部分，知情同意书（ICF）中安全性部分等。
Review or write safety related content for pre or post-marketing studyproject，such as safety information in protocol, IB or ICF and so on.
4. 撰写或审阅DSUR、PSUR及阶段性/年度安全性分析报告，死亡病例调查报告等。
Write and review DSUR, PSUR and periodic/annual safety analysisreports, Investigation report of death case, etc.
5. 负责风险管理，包括1）识别和评估研究项目中的安全风险信号；2）参与制定风险管理计划；3）协助沟通和执行风险最小化措施。
Risk management, including: 1) Identify and evaluate the safetyrisks in clinical trial. 2) Generate risk management plan. 3)Communicate and execute the risk minimization measures.
6. 负责定期为项目组的成员包括监查部提供安全性内容的培训。
Provide regular training on safety content for project team membersincluding the supervision department.
7. 负责其他医学咨询性和支持性工作。
Other medical consulting and supporting works.

任职资格/Qualifications：
1. 医学相关专业，本科及以上学历，硕士优先。
Medical science major, Bachelor, Master is preferred.
2. 能适应英文工作场景。
Be proficient in working in English scenario.
3. 拥有一年以上实际临床医生工作经验，一年以上CRO医学相关工作经验，对药物警戒行业有所了解，有global项目经验优先。
More than one year of practical clinical work experience, more than oneyear of CRO medical related work experience, understanding ofpharmacovigilance, global project experience is preferred.