Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

岗位职责:

• 负责医疗器械警戒活动在组织内部的执行，包括： 

• 国家医疗器械不良事件监测信息系统维护操作（包括用户及产品信息）； 

• 负责医疗器械不良事件的收集（包括来自国家医疗器械不良事件监测信息系统中的不良事件报告），按相关法规及内部流程的要求进行调查、分析、评价，并及时向监管机构报告。 

• 作为境外不良事件的本地接收人，完成海外事件在境内向监管机构报告的执行； 

• 负责建立和维护医疗器械不良事件相关文档； 

• 协助境外注册人完成定期风险评价报告的数据收集、文献检索、报告翻译及在国家医疗器械不良事件监测信息系统中的递交； 

• 对不良事件数据进行统计分析，发现趋势及时向直属经理提出； 

• 投诉管理，包括： 

• 依据法规和公司要求在投诉管理系统（CMS）中录入来自国家医疗器械不良事件监测信息系统中的不良事件报告； 

• 收集涉及不良事件的投诉信息协助开展投诉调查，追踪投诉进展，直至投诉关闭； 

• 其他团队间的协调工作，包括： 

• 协助执行产品放行，复核产品放行记录，如发现任何异常及时向负责同事提出； 

• 负责复核本地印刷中文标签及说明书电子样张，确保符合经批准的样稿； 

• 其他被分配的任务 

任职要求：

• 对质量管理体系有一定的理解和经验； 

• 熟悉质量文件体系； 

• 强烈的团队合作精神；良好的沟通和学习能力； 

• 优秀的口语口头和书面沟通能力； 

• 有较强的计算机基础，熟练使用Word、Excel、PPT、Outlook等软件。 

• 本科及以上学历，药学、医疗器械或相关专业优先； 

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.