職位描述
不良事件藥品警戒
崗位職責(zé):
In addition to the above:
1. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
2. Quality controls the reportability assessment of ICSR.
3. Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures; forwards the information to the Medical Director for review and processes received information in accordance with project specific instructions.
4. Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project.
5. Supports creation of the SAE/AE reconciliation plan and conducts SAE reconciliation in accordance with this plan and other project specific guidelines.
6. Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).
7. Supports signal detection and risk management activities.
8. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
9. Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
10. Serves as Lead Drug Safety Associate and coordinates small regional teams of drug safety associates and safety data coordinators on project level (not more than three individuals), serves as the drug safety point of contact for study teams on project level.
11. Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
12. Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
13. Proposes solutions for procedural and technical issues.
項(xiàng)目情況介紹：
1.國(guó)內(nèi)知名藥企腫瘤藥臨床II/III期項(xiàng)目
2.國(guó)內(nèi)知名藥企上市后產(chǎn)品
3.海外美國(guó)歐洲客戶(hù)的信息基因藥品國(guó)際多中心項(xiàng)目
任職要求:
1.醫(yī)學(xué)、藥學(xué)、流行病學(xué)、生物工程、化學(xué)相關(guān)專(zhuān)業(yè)，英語(yǔ)、日語(yǔ)等跟醫(yī)藥完全無(wú)關(guān)的專(zhuān)業(yè)不考慮
工作背景要求：
1.具備至少2年及以上PV藥物安全經(jīng)驗(yàn)優(yōu)先，
2. 純上市前PV或者純上市后PV經(jīng)驗(yàn)
3. 對(duì)過(guò)往涉及的適應(yīng)癥及臨床試驗(yàn)期數(shù)沒(méi)有要求
工作地點(diǎn)
相城區(qū)蘇州北站homebase
相似職位
- pv藥物警戒專(zhuān)員9000-11000元
蘇州 - 相城
上?？档潞胍磲t(yī)學(xué)臨床研究有限公司 - 藥物警戒專(zhuān)員8000-12000元·13薪
蘇州 - 吳江
蘇州盛達(dá)藥業(yè)有限公司
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職位發(fā)布者
顧意蓉/高級(jí)人力資源專(zhuān)員
昨日活躍立即溝通
上?？档潞胍磲t(yī)學(xué)臨床研究有限公司康德弘翼（WuXi Clinical），是藥明康德（WuXi AppTec）的一家全資子公司。始終致力為全球客戶(hù)提供全方位的臨床研究服務(wù)，包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗(yàn)。通過(guò)嚴(yán)格的質(zhì)量控制體系和專(zhuān)業(yè)團(tuán)隊(duì)的豐富經(jīng)驗(yàn)，幫助創(chuàng)新性，突破性醫(yī)藥產(chǎn)品盡快上市和造?；颊摺？档潞胍砹⒆阒袊?guó)，面向世界，以上?？偛繛橹行?，輻射全球制藥公司、生物技術(shù)公司以及醫(yī)療器械公司。目前，公司實(shí)行全球聯(lián)合運(yùn)營(yíng)，人員規(guī)模達(dá)850+人，運(yùn)營(yíng)能力覆蓋中國(guó)、美國(guó)及澳大利亞等，并在上海、北京、廣州、武漢、成都、長(zhǎng)沙、西安、沈陽(yáng)、中國(guó)臺(tái)北、美國(guó)奧斯汀、美國(guó)圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團(tuán)隊(duì)與各研究中心建立了良好的合作關(guān)系，始終保持著緊密的業(yè)務(wù)交流，保證了項(xiàng)目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展，康德弘翼進(jìn)一步完善和增強(qiáng)了全球一體化研發(fā)服務(wù)平臺(tái)的綜合實(shí)力，助力全球創(chuàng)新合作伙伴更好、更快地開(kāi)發(fā)醫(yī)藥產(chǎn)品。
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