Drug Safety Manager 上海

月薪： 20-30万/年

该公司所有职位
  • 5-7年经验
  • 硕士
  • 招若干人
  • 02-06 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 员工旅游
  • 餐饮补贴
  • 通讯补贴
  • 年终奖金
  • 弹性工作
  • 交通补贴
  • 绩效奖金

职位描述

Responsibilitiesl Receive and document incoming reports from investigative sites or other sources reporting AEs, serious adverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable; follow up with PMs to obtain missing data as required. l Create and maintain SAE reconciliation trackers for all internal studies.l Maintain CMA safety databasel Identify issues and understand the causes of those issues independently. Report any lack of safety data management issues to Quality & Compliance team.l Interfaces, collaborates, and negotiates with project members, and resolves issues with guidance as neededl Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.l Read and understand Safety Management Plan across each projects. Work with Quality & Compliance department and participate CAPA meeting if it is required.l In-depth knowledge of ICH-GCP, SOP, and local regulation. Especially familiar with safety data management within clinical trials.Competences / Skillsl Working knowledge of AE/SAE management processingl Working knowledge of applicable global, regional and local clinical research regulatory requirementsl In-depth knowledge of departmental SOPs and ICH-GCPl Strong organizational skills with the ability to meet strict deadlinesl Skill in use of multiple safety databasesl Basic project management skillsl Demonstrate a positive and flexible working attitudel Effective presentation and report writing skillsl Effective team building skillsl Effective telephone etiquette skillsl Excellent verbal and written communication skillsl Ability to work effectively on multiple projects simultaneously and effectively manage competing prioritiesl Bachelor's degree from a four-year college or university in life sciences or related field. 3-5 years clinical research pharmaceutical, or CRO company, or related organization and/or an equivalent combination of education and experience. 职能类别： 生物工程/生物制药 临床数据分析员

联系方式

上海市徐汇区宜山路1289号

公司信息

2009年12月8日，上海复星医药新药研究有限公司与美国汉霖生物技术公司正式签约合资组建上海复宏汉霖生物技术公司，致力于单克隆抗体药物的研发与产业化。公司位于上海市漕河泾新兴技术开发区，注册资本3000万美元。 复宏汉霖主要致力于应用前沿技术进行单克隆抗体药物的开发及商业化，造福更多病患。 目前公司正在开发的产品主要覆盖肿瘤、自身免疫性疾病等领域。公司以全球联动整合创新为产品开发的理念，在中国上海、美国加州和台北均设有研发实验室，配备了单抗药物前期研发所需的符合国际化标准的各项仪器设备，其中上海实验室总面积约3,000 平方米，目前在建中的实验室面积约10,000平方米。现已完成单克隆抗体药物开发平台的建设。另外，复宏汉霖率先向国内引进了先进的一次性生产技术，进行单抗产品GMP生产。借助该项优势技术，复宏汉霖现已实现5年5个产品、5项适应症IND申报的高效研发，位于同行业领先地位。展望未来，复宏汉霖人将始终以“开发优质抗体药物，造福全球病患”为使命，不断探索创新，努力耕耘，积极打造深得信赖，领先中国进而影响全球的生物制药企业。 复宏汉霖矢志成为国内领先、国际一流的生物制药公司。而人才是公司成功的最重要的根基与动力。 期待您的加盟！ 官网：http://www.henlius.com/

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