职位&公司对比

职位详情

• 上海
• 不限
• 本科

• 不限
• 医药相关专业
• Excel
• 粤语

Regulatory Compliance • Responsible for data collection, processing, documentation, reporting andBOSS直聘 follow-up of required adverse events来自BOSS直聘 (AE) reports within required timeline and quality for assigned projects; • Tracking and archiving all safety reports and documents; • Ensure compliance of PV audit and inspection in routine job and periodically review and to track, take action and close audit finding; • Notify line manager (LM) of significant issues in a timely manner. Monitor and Manage Investigational and Marketed Products Safety • Proactively review and evaluate the clinical implications of safety data from different source for assigned projects; • Review protocols, IBs and all safety sections of clinical and/or regulatory submission documents; • Draft, review SAE case follow up queries; • Draft SUSAR notification letter; • Responsible for regulatory submission for safety expedited report within required timeline and quality. • Implement other safety monitor responsibilities assigned by LM; 任职资格: • Bachelor Degree in Medicine/Master or PhD preferred • Fluent written and spoken English and Chinese • C来自BOSS直聘omputer Skill: Computer literacy, knowledge with来自BOSS直聘 • Medical PV knowledge and experience required • Good knowledge of ICH, FDA and EMA PV regulatory requirement • Good problem solving skills, communication skills ankanzhund ability to learn new knowledge • Good player to work both with a team as well as independently