Drug Safety Manager 北京

月薪： 2-2.5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 01-27 发布
  • 五险一金
  • 补充医疗保险
  • 年终奖金

职位描述

-Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases and workflow.-Build a positive, collaborative team environment with project team members; provide training and mentoring for project team members and department staff; assist management with allocating resources to projects.-Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities.-Participate in internal audits for assigned projects. Liaise with Quality Assurance staff and overall management in the compilation of CAPs.-Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend and represent assigned projects at financial meetings.-Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent feedback to department managers on staff quality and progression.-Provide regular reports to overall project manager and department management on project metrics, SOW changes; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports.-Drive case follow-up and closure processes; process cases as needed.-Assist senior leaders in managing department by identifying, developing and implementing new processes and systems designed to improve quality and efficiency, updating managers on new regulations, representing department at sales, marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions (WIs).-Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.Job Requirements：-In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and post marketing areas.-In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.-In-depth knowledge of departmental standard operating procedures (SOPs).-Skill in use of multiple safety databases.-Strong project management skills.-Strong coaching and team building skills.-Excellent written communication skills.-Ability to lead projects within strict deadlines.-Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities.-Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff and regulatory agency representatives. 职能类别： 生物工程/生物制药 关键字： 药品安全

联系方式

北京市 西城区

公司信息

西藏晨泰医药科技有限公司成立与2017年1月，在上海、北京有办公室，目前主要从事肿瘤药物开发。

北京相关职位

当前位置： 首页> 西藏晨泰医药科技有限公司> Drug Safety Manager

北京相关职位： 研发企划主管(J10796) 现场QA(J10853) 冻干车间生产工人 药品质量控制专员（QC） 放行QA 医学顾问 区域推广经理（北京）(J10594) QA（现场/放行/验证）(J10957) 制剂研究员（外用制剂优先）(J10961) 区域经理（北京）(J10324)

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： 2018-01-08

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