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藥物警戒專員-上海（Contract）

8000-9000元
  • 上海長(zhǎng)寧區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招999人

雇員點(diǎn)評(píng)標(biāo)簽

  • 同事很nice
  • 工作環(huán)境好
  • 團(tuán)隊(duì)執(zhí)行強(qiáng)
  • 人際關(guān)系好
  • 氛圍活躍
  • 管理人性化
  • 實(shí)力大公司
  • 交通便利

職位描述

藥品警戒
崗位職責(zé):
Regulatory Compliance
?Responsible for data collection, processing, documentation, reporting and follow-up of required adverse events (AE) reports within required timeline and quality for assigned projects;
?Tracking and archiving all safety reports and documents;
?Ensure compliance of PV audit and inspection in routine job and periodically review and to track, take action and close audit finding;
?Notify line manager (LM) of significant issues in a timely manner.
Monitor and Manage Investigational and Marketed Products Safety
?Proactively review and evaluate the clinical implications of safety data from different source for assigned projects;
?Review protocols, IBs and all safety sections of clinical and/or regulatory submission documents;
?Draft, review SAE case follow up queries;
?Draft SUSAR notification letter;
?Responsible for regulatory submission for safety expedited report within required timeline and quality.
?Implement other safety monitor responsibilities assigned by LM;
任職要求:
?Bachelor Degree in Medicine/Master or PhD preferred
?Fluent written and spoken English and Chinese
?Computer Skill: Computer literacy, knowledge with
?Medical PV knowledge and experience required
?Good knowledge of ICH, FDA and EMA PV regulatory requirement
?Good problem solving skills, communication skills and ability to learn new knowledge
?Good player to work both with a team as well as independently

工作地點(diǎn)

長(zhǎng)寧區(qū)上海中山西路999號(hào)華聞國(guó)際大廈16樓

職位發(fā)布者

程紅/招聘

今日活躍
立即溝通
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泰格醫(yī)藥(股票代碼:300347.SZ/3347.HK)是行業(yè)領(lǐng)先的一體化生物醫(yī)藥研發(fā)服務(wù)平臺(tái)，為全球制藥和醫(yī)療器械行業(yè)提供跨越全周期的臨床研究創(chuàng)新解決方案。通過(guò)全面的服務(wù)體系和頂尖的質(zhì)量標(biāo)準(zhǔn)，我們助力生物醫(yī)藥產(chǎn)業(yè)提升研發(fā)效率、降低研發(fā)風(fēng)險(xiǎn)，確保研究項(xiàng)目高質(zhì)量交付，加速醫(yī)藥產(chǎn)品市場(chǎng)化進(jìn)程，履行對(duì)行業(yè)和患者的承諾。同時(shí)，我們也通過(guò)覆蓋各領(lǐng)域的 100多家子公司，打造賦能全產(chǎn)業(yè)鏈的創(chuàng)新生態(tài)，推動(dòng)醫(yī)療產(chǎn)業(yè)創(chuàng)新和發(fā)展。作為全球化的研發(fā)平臺(tái)，泰格醫(yī)藥在全球布局 180多個(gè)辦事處和分支機(jī)構(gòu)，擁有超過(guò) 9500人的專業(yè)團(tuán)隊(duì)，覆蓋5大洲的 54個(gè)國(guó)家，致力于解決最具挑戰(zhàn)的全球健康問(wèn)題，滿足患者的未盡醫(yī)療需求，創(chuàng)造社會(huì)價(jià)值，造福人類健康。更多詳情請(qǐng)登錄：http://tigermed.zhiye.com/或?qū)⒛暮?jiǎn)歷發(fā)送至：TA@tigermedgrp.com（請(qǐng)務(wù)必在郵件主題中注明：意向地區(qū)+意向崗位+姓名）
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