Clinical Safety Specialist (Contractor)招聘_美敦力（上海）管理有限公司最新招聘信息-猎才医药网

职位描述

职位描述： POSITION RESPONSIBILITIES:- Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).- Conduct Case Management in the Clinical Safety Database.- Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.- Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies).- Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.- Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).- Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)- Write Clinical Safety plan for assigned protocol(s).- Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.- Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.- Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.- Performs other duties as assigned.QUALIFICATIONS:- Good written, oral, and interpersonal communication skills including knowledge of medical terminology.- Proficient with MS Office products, word processing, spreadsheets, etc.- High attention to detail and accuracy and ability to manage multiple tasks.- Good prioritization and organizational skills.- Excellent problem solving skills- Flexible and dependable.- Works effectively on cross-functional teams.- Bachelor’s degree , 2+ yrs safety experience- Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.- Fluent with medical terminology 职能类别：临床研究员关键字：药物安全

公司信息

医疗科技，生命所系美国美敦力公司(medtronic,inc.)总部位于美国明尼苏达州明尼阿波利斯市，是一家在全球居于领先地位的医疗技术公司，致力于为慢性病患者提供终身的解决方案，全球员工超过36000名。2006财政年度，美敦力的销售额达113亿美元，。在过去的岁月里，美敦力已经为专业医务人员提供了医疗产品及治疗方案，每年帮助逾500万的患者改善了生活品质。美敦力的主要产品覆盖了以下领域：心律失常、心衰、血管疾病、心脏瓣膜置换、体外心脏支持、微创心脏手术、恶性及非恶性疼痛、运动失调、糖尿病、胃肠疾病、泌尿系统疾病、脊椎疾病、神经系统疾病及五官科手术治疗。世界上每4秒就有一名患者因美敦力的产品而改善生活质量；在中国，每8分钟就有一位病人的健康因美敦力的产品而得到改善。与此同时，公司和员工的贡献与成就也不断得到了多家权威机构及专业期刊的认可。进入中国10年来，美敦力向中国提供的慈善和教育捐赠累计已超过270万美元；2005年，美敦力中国荣膺“中国企业客户关怀80强”称号，是惟一入选的医疗器械公司。以下是美敦力获得的部分荣誉： · 被《财经时代》评为全球最大的500家公司之一； · 在《business week》业绩最好的50家大公司排行榜上位列第21位； · 在《business week》全球1000家市值最高公司排行榜上位列第54位（2002年第59位）； · 在《福布斯》500家***业绩年度排行榜上排名第111位； · 被《财富》杂志评为100家最值得赞赏的公司之一，并位于该行业第一位。同时，还在"长期投资价值"、"产品质量和服务"及"创新"三大类中名列前三位。 · 连续七年被《财富》杂志评为美国“100家***雇主”之一美敦力公司为员工提供具有竞争力的薪资福利，完善的培训与职业发展计划。欢迎符合条件的优秀专业人才加入。 international website：http://www.medtronic.com china website：http://www.medtronic.com.cn 美敦力寻找千里马活动 - 人事篇 http://www.myjob500.com/detail.aspx?type=1&id=2238

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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