Key Result Areas 主要领域
Safety report management 安全性报告管理
61maintain and receive safety report from all in-take channels
维护和接收各渠道来源的安全性报告
61 Handle safety report from all sources (clinical studies, spontaneous, literatures, NMPA, etc.), including:
- Data review, coding, translation and communication
- Report to global Data entry site
- Report to Health Authorities
- Query answering
- Tracking and archiving
- Late case communication and complete CAPA
处理各种来源（包括临床研究、自发报告、文献、NMPA 反馈等）的安全性报告, 包括：
- 数据审查、编码、翻译和交流
- 报告至全球数据录入中心
- 报告至当地监管机构
- 解答质疑
- 跟踪和存档
- 沟通迟报案例并完成CAPA
61 QC peers and/or vendor’s case
检查来自其他同事和/或供应商报告的质量
61 Support team members and provide training to new staff
支持团队成员，为新员工提供培训
Other其他
61 Support or perform any other task that management deems appropriate.
支持或执行管理层认为适当的任何其他任务
Academic / Professional Qualification
61 Bachelor's degree in medical, pharmacy or other relevant majors
医学、药学、或相关专业学士及以上
61 Familiar with PV laws and regulations, ensure the quality of various PV surveillance work
熟悉药物警戒法律法规，确保各项药物警戒工作质量
61 Familiar with GCP
熟悉GCP
61 Good organizational skills with the ability to multi-task and prioritize assignments (planning and organizing)
良好的组织能力，能够同时处理多项任务并确定任务的优先级（计划和组织）
61 Good verbal and written communication skills
良好的口头和书面沟通技巧
61 Good project management and problem solving skills
良好的项目管理和解决问题的能力
61 Proficient in common office software and office equipment operation skills
熟练掌握常用办公软件和办公设备操作技巧
61 At least 0-1 year working experience in Pharmacovigilance
0-1 年以上药物警戒相关工作经验