长沙招聘

工作职责:

Regulatory Compliance

? Responsible for data collection, processing, documentation, reporting and follow-up of required adverse events (AE) reports within required timeline and quality for assigned projects;

? Tracking and archiving all safety reports and documents;

? Ensure compliance of PV audit and inspection in routine job and periodically review and to track, take action and close audit finding;

? Notify line manager (LM) of significant issues in a timely manner.

Monitor and Manage Investigational and Marketed Products Safety

? Proactively review and evaluate the clinical implications of safety data from different source for assigned projects;

? Review protocols, IBs and all safety sections of clinical and/or regulatory submission documents;

? Draft, review SAE case follow up queries;

? Draft SUSAR notification letter;

? Responsible for regulatory submission for safety expedited report within required timeline and quality.

? Implement other safety monitor responsibilities assigned by LM;

任职资格:

? Bachelor Degree in Medicine/Master or PhD preferred

? Fluent written and spoken English and Chinese

? Computer Skill: Computer literacy, knowledge with

? Medical PV knowledge and experience required

? Good knowledge of ICH, FDA and EMA PV regulatory requirement

? Good problem solving skills, communication skills and ability to learn new knowledge

? Good player to work both with a team as well as independently

泰格医药是行业领先的一体化生物医药研发服务平台，为全球制药和医疗器械行业提供跨越全周期的临床研究创新解决方案。通过全面的服务体系和***的质量标准，我们助力生物医药产业提升研发效率、降低研发风险，确保研究项目高质量交付，加速医药产品市场化进程，履行对行业和患者的承诺。同时，我们也通过覆盖各领域的80多家子公司，打造赋能全产业链的创新生态，推动医疗产业创新和发展。作为全球化的研发平台，泰格医药在全球布局170多个办事处和研发基地，拥有超过8600人的专业团队，覆盖5大洲的51个国家，致力于解决最具挑战的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。