Regulatory Compliance
• Responsible for data collection, processing, documentation, reporting and follow-up of required adverse events (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
• Computer Skill: Computer literacy, knowledge with
• Medical PV knowledge and experience required
• Good knowledge of ICH, FDA and EMA PV regulatory requirement
• Good problem solving skills, communication skills and ability to learn new knowledge
• Good player to work both with a team as well as independently