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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