職位描述
?
職位職能:
??臨床協(xié)調(diào)員??護(hù)士/護(hù)理人員
職位描述:
工作職責(zé) 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.
協(xié)助藥物安全專員對來自于申辦方和醫(yī)學(xué)部的上市后藥物的藥物不良反應(yīng)及其后續(xù)報(bào)告進(jìn)行管理、報(bào)告、翻譯（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.
協(xié)助藥物安全專員上市后藥物的藥物不良反應(yīng)上報(bào)國家及當(dāng)?shù)乇O(jiān)管部門，并將上報(bào)信息反饋給申辦方及醫(yī)學(xué)部。
3.Assist DSO to manage reporting/submission of all serious adverse event in the clinical trial to SFDA/pFDA as per national requirements.
協(xié)助藥物安全專員對來自于臨床試驗(yàn)中嚴(yán)重不良事件，按照國家相關(guān)法規(guī)要求上報(bào)國家及地方藥品食品監(jiān)督管理部門。
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.
協(xié)助藥物安全專員對于來自于申辦方的SUSAR，按照法規(guī)及申辦方要求及時(shí)上報(bào)國家相關(guān)監(jiān)管部門，并及時(shí)分發(fā)給醫(yī)學(xué)部以遞交研究者及倫理委員會(huì)。
5.Assist DSO to manage and maintain efficient tracking system of SAE & ADR reporting/submission.
協(xié)助藥物安全專員進(jìn)行臨床試驗(yàn)中嚴(yán)重不良事件及上市后藥物不良反應(yīng)上報(bào)管理及追蹤。
6.Manage and maintain efficient filing and archive system.
定期查閱中國藥物警戒條例，確保我們的遞交流程符合現(xiàn)行操作及法規(guī)。
任職要求 Qualifications
1.At least Nursing relative background.護(hù)理相關(guān)專業(yè)本科及以上學(xué)歷。
2.Familiar with the knowledge of the SFDA regulatory requirement about Pharmocovigilance, GCP and the SOP of AE/SAE mangagement. 熟悉SFDA藥物警戒相關(guān)法規(guī)知識(shí)，GCP，AE/SAE管理操作標(biāo)準(zhǔn)流程。
3.At least 1-year experience in hospital，pharmacy，pharmaceutical or CRO. 至少1年在醫(yī)院、藥房、藥廠或CRO 工作經(jīng)驗(yàn)。
4.CET4,fluent in written English.CET4，讀寫流利。
