长沙招聘

Responsibilities：

?Process and distribute safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies, and procedures.
?Triage domestic and foreign safety reports received by the client and reporter, appropriately scheduling case reports in the safety database based on the following criteria: source, seriousness, data entry priority, initial vs. follow-up report.
?Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and perform necessary checks for duplicate cases.
?Exercise judgment and use knowledge of applicable regulations and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness.
?Enter appropriate data into the safety database in a timely manner, utilizing management-determined data entry guidelines.
?Generate narrative case summaries according to Wuxi-PRA standards.
?Code all adverse event terminology, other medical information, and drug information in the safety database utilizing MedDRA and WHO-DD dictionaries, in accordance with the coding policies and standards.
?Liaise with assigned Physicians in Drug Safety, Clinical Science and/or Medical Affair to ensure that appropriate medical review and assessment is provided for assigned case reports.
?Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge.
?Perform follow-up as needed, either directly with reporter, through Call Center, client, or through appropriate CRAs, and documents results in case file.
?Ensure that required follow-up for assigned cases has been completed.
?Communicate with partner companies, client, and manager regarding the evaluation and processing of case reports.
?Create and maintain electronic and/orhard copy case files as per the client SOPs and guidelines.
?Produce and distribute expedited and non-expedited individual case safety reports to regulatory authorities, partner companies, EC, investigators, and clients, as needed, to ensure compliance with regulatory and company timelines.
?Cooperate with clinical data management to conduct SAE reconciliation.

任职要求：
1、临床医学本科及以上学历；
2、CET6，英语流利；
3、善于学习，有责任心，良好的沟通协调能力。

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。