Pharmacovigilance Senior Manager 上海

月薪： 1-2万/月

该公司所有职位
  • 2年经验
  • 硕士
  • 招1人
  • 03-03 发布
  • 专业培训
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 定期体检
  • 弹性工作
  • 年终奖金

职位描述

POSITION SUMMARY Lead large safety operation related project activities are completed on-time, within budget and meet quality standards. Obtain and process 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. RESPONSIBILITIES 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 client meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities. Participate in client and 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, client requests or concerns; 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 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. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 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 skills Strong 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, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients 职能类别： 医药技术研发人员 生物工程/生物制药 关键字： PV Drug Safety 药物警戒 药物安全

联系方式

黄陂南路（地址1号线新天地站，9、10、13号线马当路站）

公司信息

PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。

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当前位置： 首页> 上海百利佳生医药科技有限公司> Pharmacovigilance Senior Manager

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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： 2018-02-04

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