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工作地点 浦东新区 工作经验 1年以上 学历要求 本科
语言类别 不限 招聘人数 1人 工作类型 全职
性别要求 不限 年龄要求 不限
更新日期 2021-04-21

岗位职责:


1.Receive, track, process, and report SAE and AEs of Special Interest cases from clinical trials, within the required timeframe for regulatory reporting and data exchanging with HMP’s partners;
2.Perform the case assessment for completeness, accuracy and legibility; Interpret source documents including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries;
3.Produce or review the clinical safety queries as needed for case clarification;
4.Prepare safety periodic reports, e.g. Safety line listings, safety summary, with the required timeline;
5.Interact on a regular basis with contract drug safety vendor (CRO safety team) to resolve safety-related issues in case processing;
6.Be involved in case medical review for seriousness, expectedness, and causality;
7.Be involved in generating and distributing the Safety Notification Letters of SUSARs, Clinical or Pre-clinical Safety Findings;
8.Serve as a Safety Liaison Contact to other functions in clinical development for the assigned clinical projects;
9.Complete the assignments in clinical projects, e.g. Review of safety management plans, safety sections of clinical protocols and CSRs, and others;
10.Others, e.g. SOPs drafting, reviewing and maintenance.


职位要求:


1.A bachelor degree or above, in medicine ( highly preferred), public health, nursing or other health disciplines;
2.1-2 years working experience in pharmacovigilance, clinical research, or medical affairs;
3.Knowledge of ICH/FDA/EMA/CFDA regulations/guidance for pharmacovigilance, and be familiar with GCP;
4.Fluent in both written and spoken English;
5.Good communication skills and computer skills.


企业简介:

和记黄埔医药(上海)有限公司(和记黄埔医药)是一家由香港和记黄埔有限公司(和黄)全资投资的医药研发企业。和黄成立于十九世纪,是香港著名的跨国公司,现已成为全球500强企业之一。
和记黄埔医药2002年9月成立,位于上海张江高科技园区,公司致力于为全球市场开发创新药物。和记黄埔医药拥有一套完整的药物研发体系和一流的研发平台。公司的高级管理层主要来自美国的世界知名医药及生物科技公司,拥有丰富的....>>详情


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企业名片
和记黄埔医药(上海)有限公司
企业性质:外商独资
员工人数:100-500人
公司主页:http://www.hmplglobal.com
联系方式
邮政编码:201203
联系电话:021-20673000-6012
公司地址:上海市浦东新区张江高科技园区蔡伦路720弄4号楼
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