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HR · 泰格医药

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职位介绍: Roles and Responsibilities 1. Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality. 2. Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR, pharmacovigilance annual report) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments. 3. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data. 4. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable. 5. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization. 6. Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements. 7. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information. 8. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources. 9. Management and maintenance of all relevant Patient Safety databases. 10. Ensure that relevant local literature articles are screened as appropriate. 11. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed. 12. Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable. 13. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections. 14. Ensure training and oversight of staff, as applicable. 15. Manage and maintain efficient Patient Safety filing and archive system. 16. Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial Ideal Background Education (minimum/desirable): Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience Languages: • Fluent in both written and spoken English • Fluent in both written and spoken local language Experience/Professional requirement: • Knowledge of national and international regulations for pharmacovigilance • Knowledge of pharmacological and medical terminology. • Excellent communications, interpersonal and negotiation skills • Quality and focus oriented • Computer skills • Additional educational requirements as may be mandated by national requirements

其他信息: 所属部门：FSP

公司简介

泰格医药(股票代码:300347.SZ/3347.HK)是一体化的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超高的质量标准，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 100 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 180 多个办事处和分支机构，拥有超过 9500人的专业团队，覆盖5大洲的 54个国家，致力于解决具有挑战性的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。更多详情请登录：************************** 或将您的简历发送至：****************** （请务必在邮件主题中注明：意向地区+意向岗位+姓名）

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