职位描述
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职位职能:
??临床协调员??护士/护理人员
职位描述:
工作职责 Responsibilities
1.Assist Drug Safety Officer to manage processing, reporting, translation (if needed) and follow-up of all adverse drug reactions report of post-marketing products from sponsor and clinical operation department.
协助药物安全专员对来自于申办方和医学部的上市后药物的药物不良反应及其后续报告进行管理、报告、翻译（如有需要）。
2.Assist DSO to manage reporting/submission of all adverse drug reactions report of post-marketing products to Local Health Authority. Feedback submission information to sponsor/ or clinical operations.
协助药物安全专员上市后药物的药物不良反应上报国家及当地监管部门，并将上报信息反馈给申办方及医学部。
3.Assist DSO to manage reporting/submission of all serious adverse event in the clinical trial to SFDA/pFDA as per national requirements.
协助药物安全专员对来自于临床试验中严重不良事件，按照国家相关法规要求上报国家及地方药品食品监督管理部门。
4.Based on the regulatory requirement & sponsor’s requirement, assist DSO to manage reporting/submission of all SUSARs from sponsor to the related health authority, distributing all SUSARs to clinical operation department to do submission to the related investigator & EC.
协助药物安全专员对于来自于申办方的SUSAR，按照法规及申办方要求及时上报国家相关监管部门，并及时分发给医学部以递交研究者及伦理委员会。
5.Assist DSO to manage and maintain efficient tracking system of SAE & ADR reporting/submission.
协助药物安全专员进行临床试验中严重不良事件及上市后药物不良反应上报管理及追踪。
6.Manage and maintain efficient filing and archive system.
定期查阅中国药物警戒条例，确保我们的递交流程符合现行操作及法规。
任职要求 Qualifications
1.At least Nursing relative background.护理相关专业本科及以上学历。
2.Familiar with the knowledge of the SFDA regulatory requirement about Pharmocovigilance, GCP and the SOP of AE/SAE mangagement. 熟悉SFDA药物警戒相关法规知识，GCP，AE/SAE管理操作标准流程。
3.At least 1-year experience in hospital，pharmacy，pharmaceutical or CRO. 至少1年在医院、药房、药厂或CRO 工作经验。
4.CET4,fluent in written English.CET4，读写流利。
