岗位目的：
This position is the senior drug safety physician who can independently complete the safety assessment and risk management of clinical development products and/or post-marketing products. The main tasks include medical review of individual case safety reports, management of aggregated safety reports, safety signal management and risk management of clinical development products and/or post-marketing products, etc.
该岗位是高级药物安全医生，能独立完成负责的临床研发产品和/或上市后产品的安全评估及风险管控相关工作。主要工作内容包括个例安全报告医学审评、汇总性安全报告的管理、临床研发产品和/或上市后产品的安全信号管理及风险管理等。

岗位职责：
1) For responsible products, with designated cross-functions members, perform product’s signal management and risk management, understand its safety information, identify and evaluate the important risks of the product in the clinical development stage and/or marketing stage together, and make corresponding risk control measures. And throughout the product life cycle, continuously and timely review the product safety information. The safety information of the product includes but is not limited to the safety data of the clinical trial of the product, spontaneous reports after the product is marketed, literature, etc. Identify and assess whether the product has new safety signals or risks by reviewing the safety information of the product. When necessary, add or update risk management and control measures in a timely manner to ensure the balance of risk and benefit for patients. Be responsible for and maintain a risk management program for product safety.
对于负责的产品的信号管理和风险管理，了解其安全信息，与跨部门合作一起识别和评估产品的在临床研发阶段和/或上市阶段的重要风险，并制定相应的风险管控措施。并在产品的整个生命周期，持续和及时的审核产品的安全性信息。产品的安全信息包括但不限于产品临床试验的安全性数据，产品上市后自发报告、文献等。通过对产品的安全性信息的审核以识别和评估产品是否有新的安全性信号或风险。必要时及时添加或更新风险管控措施，以确保患者的风险获益平衡。负责和维护产品安全的风险管理计划。
2) Support aggregated safety reports of responsible products The s aggregated safety reports mainly refers to the periodic safety report of the product and the product safety information in the investigator's brochure/ insert/clinical trial protocol/registration documents and so on.
支持负责的产品汇总性安全性报告。汇总性安全性报告主要是指产品的定期安全性报告及研究者手册/说明书/临床试验方案/注册资料中的产品安全性信息。
3) Perform the medical review of individual case safety reports of responsible products. The medical review of individual case safety reports mainly includes: medical coding review, assessment of the severity/expectness/causality of adverse events, providing medical review comments, raising medical queries, etc.; at the same time, it is necessary to evaluate whether the report indicates new safety signal
负责产品的个例安全报告的医学审核。个例报告进行医学审核主要包括：医学编码审核，不良事件的严重性/预期性/因果关系评估, 提供医学评审意见，提出医学质疑等；同时需要评估该报告是否提示了产品的新的安全性信号。


任职资格:
1.学历背景：硕士及以上学历，医学、药学、生物学等相关专业，临床医学专业优先；
2.工作经验：3年以上药物警戒相关经验；
3.专业知识：熟悉国内外药物警戒相关法律法规及指南；
4.技能要求：英语流利。