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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 分享 邮件
- 年龄要求: 不限
- 语言要求:不限
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工商信息
- 公司名称: 上海百利佳生医药科技有限公司
- 公司状态: 存续
- 行业: 科技推广和应用服务业
- 公司类型: 有限责任公司(外商投资企业法人独资)
- 地址: 上海市黄浦区南苏州路373-381号409M08室
- 企业规模: -
- 法人代表: 朱俊
- 注册资本: 4500万人民币
- 注册时间: 2017年11月17日
- 注册号: 310101000748207
- 统一社会信用代码: 91310101MA1FP91H9M
- 组织机构代码: MA1FP91H9
- 登记机关: 黄浦区市场监督管理局
- 注册地址: 上海市黄浦区南苏州路373-381号409M08室
- 营业期限: 2017-11-17至2047-11-16
- 核准日期: 2017年11月17日
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经营范围:
从事医药科技领域内的技术开发、技术转让、技术咨询、技术服务,货物及技术的进出口业务。【依法须经批准的项目,经相关部门批准后方可开展经营活动】
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企业简介
上海百利佳生医药科技有限公司
- 行业: 房地产/建筑/建材/工程
- 规模: 1-100人
- 性质: 其他
- 当前职位: Pharmacovigilance Senior Manager
PPC佳生(PPC Group)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。 1997年至今,PPC佳生已经完成了超过2000项早期临床试验项目,其中包括创新药I期研究、仿制药生物等效性研究以及生物类似药早期临床研究(包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD)。同时,PPC佳生也已经完成超过400项II期至IV期临床试验项目,其中涉及24个主要研究领域。 目前PPC佳生是亚太区域唯一通过日本PMDA,欧盟ANSM,东盟NCPB,美国FDA和中国CFDA核查的临床基地。 2017 TPG集团注资佳生,注册成立上海百利佳生医药科技有限公司。
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