摘要
About the Role
~ 根据交付活动的需求提供支持，即共同撰写安全文件，协助为监管和临床文件以及临时卫生局查询提供安全输入。
~ 协助监控产品的安全状况，包括文献综述、个别病例的医疗审查/评估或信号检测等活动。
~ 执行文献评论
~ 支持为卫生局准备特别查询，特别是短期通知请求。
~ 就卫生当局评估报告开展后续活动。
~ 协助为监管事务和临床文件提供安全输入。支持本地偏差的维护和管理
~ 协助评估和编写分配的其他安全交付成果
~ 根据需要为新指示提交（监管文档安全输入）提供支持。
~ 准备对内部安全请求的响应和对外部安全查询响应的贡献。
~ 担任医疗运营/医疗职能的学科专家（SME）
~ 领导初级团队成员/同事的培训和指导
~ 营销样本的分发（如适用）
Key Performance Indicators
• 安全分析、解释和演示的及时性和质量
• 遵守内部和外部法规和程序
• 安全交付成果的合规性、一致性和质量
Work Experience
~运营管理和执行
~项目管理
~跨界协作
~职能广度
~人员挑战
~管理危机
Skills
~临床研究
~过程安全
~法规遵从性
~职能团队
~安全科学
~文献综述
~病案
~临床试验
Language
英语
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
