药物警戒专员
科文斯医药研发(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-11-24
- 工作地点:大连
- 招聘人数:20人
- 工作经验:1年经验
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:8-10万/年
- 职位类别:临床数据分析员
职位描述
- maintenance of adverse event tracking systems
- set-up and maintenance of project files, core process files and central safety files
- reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.
- Provide administrative support to PV&DSS personnel (e.g. proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).
- Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA).
- Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
- Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA/Sr. DSA.
- Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
- Coordinate shipments of safety documents.
- Prepare and coordinate safety study files for archiving at completion of projects.
- Arrange and schedule internal and external meetings/teleconferences.
- Train and mentor the PV&DSS Support Specialists in their day-to-day activities.
- Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
- Build and maintain good PV&DSS relationships across functional units.
- Any other duties as assigned by management.
本科以上学历,生命科学相关专业;
- 一年以上临床相关经验, 药物安全、药物警戒,PV 相关经验者优先
- Supervisory experience, but not necessarily line management experience.
- Office experience or equivalent training.
- Ability to set priorities and handle multiple tasks.
- Pays attention to detail.
- Good team player.
- Good written and verbal communication skills.
- Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Ability to operate standard office equipment.
公司介绍
LabCorp是全球顶尖的生命科学公司,科文斯作为LabCorp旗下的药物研发部门,肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球,在世界范围内拥有超过26000名员工,卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年,科文斯中国团队共参与了近100个获得上市许可的新药研发,积极支持超过50个免疫肿瘤药物的研发项目,是服务***面的药物研发公司。
欢迎加入科文斯中国团队,我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号,通过移动端迅速查询热招职位并投递申请,与我们并肩实现#CovancePotential。
欢迎加入科文斯中国团队,我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号,通过移动端迅速查询热招职位并投递申请,与我们并肩实现#CovancePotential。
联系方式
- Email:yuanxin.fang@covance.com
- 公司地址:地址:span浦东新区伽利略路338号9号楼