工作職責:
崗位目的：
This position is the senidrug safety physician who can independently complete the safety assessment risk management of clinical development products and/post-marketing products. The main tasks include medical review of individual case safety reports, management of aggregated safety reports, safety signal management risk management of clinical development products and/post-marketing products, etc.
該崗位是高級藥物安全醫生，能獨立完成負責的臨床研發產品和/或上市后產品的安全評估及風險管控相關工作。主要工作內容包括個例安全報告醫學審評、匯總性安全報告的管理、臨床研發產品和/或上市后產品的安全信號管理及風險管理等。
崗位職責：
1) Fresponsible products, with designated cross-functions members, perform product’s signal management risk management, understits safety information, identify evaluate the important risks of the product in the clinical development stage and/marketing stage together, make corresponding risk control measures. throughout the product life cycle, continuously 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 assess whether the product has new safety signals risks by reviewing the safety information of the product. When necessary, add risk management control measures in a timely manner to ensure the balance of risk benefit fpatients. Be responsible fmaintain a risk management program fproduct safety.
對于負責的產品的信號管理和風險管理，了解其安全信息，與跨部門合作一起識別和評估產品的在臨床研發階段和/或上市階段的重要風險，并制定相應的風險管控措施。并在產品的整個生命周期，持續和及時的審核產品的安全性信息。產品的安全信息包括但不限于產品臨床試驗的安全性數據，產品上市后自發報告、文獻等。通過對產品的安全性信息的審核以識別和評估產品是否有新的安全性信號或風險。必要時及時添加或更新風險管控措施，以確保患者的風險獲益平衡。負責和維護產品安全的風險管理計劃。
2) Support aggregated safety reports of responsible products The s aggregated safety reports mainly refers to the periodic safety report of the product the product safety information in the investigators brochure/ insert/clinical trial protocol/registration documents so on.
支持負責的產品匯總性安全性報告。匯總性安全性報告主要是指產品的定期安全性報告及研究者手冊/說明書/臨床試驗方案/注冊資料中的產品安全性信息。
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
負責產品的個例安全報告的醫學審核。個例報告進行醫學審核主要包括：醫學編碼審核，不良事件的嚴重性/預期性/因果關系評估，提供醫學評審意見，提出醫學質疑等；同時需要評估該報告是否提示了產品的新的安全性信號。
