This role will be charged with the safety monitoring activities for PMS studies in Japan， in collaboration with the PMS team and the relevant program teams for each therapeutic area. This individual has the required medical and scientific expertise and is able to integrate the input from various disciplines to help create， maintain， and support the execution of the PMS studies in Japan that will support the company’s business objectives.
・Review and provide input into the study protocol as it is developed.
・Perform and coordinate PMS start‐up activities to ensure applicable timelines and metrics are met， including all regulatory， legal and financial aspects in accordance with the local guidelines and SOPs. These include， but are not limited to site and investigator selection， collection and review of critical documents， preparation and submission of dossier for review and approval of relevant authorities.
・Provide training on the protocol and proper conduct of PMS…
大卒/Degree in Health Sciences preferred
Previous experience in monitoring PMS or clinical trials preferred