Role at a glance
- Salary
- Not Disclosed
- Location
- Shanghai, China
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- Senior Level 有5年及以上药物警戒相关工作经验
- Education
- 医学、药学、流行病学等专业本科以上学历
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Role Summary
Senior drug safety role focused on collecting and managing clinical trial and post-marketing safety information, quality-reviewing safety report processing, and supporting pharmacovigilance reporting to regulators. The posting describes a standard Monday to Friday schedule in an office environment.
What You'll Do
- Collect and manage clinical trial and post-marketing safety information for the company and, when needed, similar products from other...
- Perform quality review of safety report processing, including database handling and translation in safety reporting
- Report drug safety information to regulatory authorities and other parties within required timelines, and maintain and archive related...
- Write and update implementation documents such as safety management plans (SMP) and training materials
- Review clinical trial and post-marketing project documents such as protocols and Investigator's Brochures (IB)
- Support or write pharmacovigilance summary reports such as DSUR, PSUR, MAH annual pharmacovigilance reports and RMP, and coordinate with...
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor's or higher in medicine, pharmacy, epidemiology or a related field, with 5+ years of pharmacovigilance experience.
Required
- Bachelor's degree or higher in medicine, pharmacy, epidemiology or similar fields
- 5+ years of pharmacovigilance-related work experience
- Knowledge of medicine, pharmacy, nursing and epidemiology, with ability to investigate, analyze, evaluate and process adverse drug...
- Familiarity with domestic and international regulations
- Familiarity with medical literature search methods
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Description:
- 根据国内外药物警戒相关法规及公司内部的药品安全信息管理的相关规定，管理收集本公司和其他公司同类产品（必要时）的临床试验及上市后安全信息；
- 对安全报告处理及递交进行质量审核，包括安全性报告在数据库中的处理以及药品安全性信息报告过程中的翻译等；
- 在规定时限内，将药品安全信息报告给监管机构以及其他相关方，并对相关文件进行维护和归档；
- 根据需要撰写并更新具体实施过程中的相关文件，如临床试验中安全管理计划（SMP）、培训材料等项目相关材料；
- 审阅临床试验项目及上市后项目的相关文件，如临床试验方案、研究者手册（IB）等；
- 支持或撰写药物警戒汇总性报告，如研发期间药物安全性更新报告（DSUR）、定期安全性更新报告（PSUR）、上市许可持有人（MAH）药物警戒年度报告、风险管理计划（RMP）等；
- 与公司内部及外部相关部门进行合作与交流，管理药品安全信息的跟踪调查工作；
- 需要委托外部管理临床试验或上市后药品安全信息的，需负责对外部单位进行管理和协调；
- 根据需要对产品不良事件进行分析，并将分析结果反馈到相应部门；
- 支持临床和注册回答当地药品监管部门及伦理委员会提出药物警戒相关的疑问；
- 负责新员工的培训与指导；
- 协助完成上级领导安排的其他工作任务。
Qualification:
- 医学、药学、流行病学等专业本科以上学历；
- 有5年及以上药物警戒相关工作经验；
- 掌握医学、药学、护理学、流行病学等专业知识，具备调查、分析、评价、和在数据库中处理药品不良反应报告的能力；
- 熟悉国内外法规；熟悉医学文献检索方法；
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.