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;
任職資格:
? 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