• Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports; determining initial/update status of incoming events; and tracking timelines for completion of events. As required, assist with entering data into Lifecycle Safety databases, submitting event data to Operational Team members, tracking submission, and assume workflow responsibilities for assigned projects. Respond to basic and routine… Show more • Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports; determining initial/update status of incoming events; and tracking timelines for completion of events. As required, assist with entering data into Lifecycle Safety databases, submitting event data to Operational Team members, tracking submission, and assume workflow responsibilities for assigned projects. Respond to basic and routine inquiries of a technical nature through case management.• Prepare documents, files for meetings and committees where required i.e. endpoint duplication/dossier compilation oversight committees; and any other project related meetings.• Co-ordinate and check incoming documents from sites; review with checklist; ensure documents meets requirements in advance of further level review in conjunction operations team member.• Create, track and archive case folders and project files across Lifecycle Safety service lines. File, retrieve and deliver case folders; assist in maintenance of document control room where required and support relevant applications/systems as directed by Operations Team member.• Assist with the distribution of Lifecycle Safety data to investigators, marketing authorization holders, customers and regulators. May coordinate, schedule and submit reports to regulatory authorities in accordance with established deadlines. Assist with investigator mailings by creating labels using investigator lists, copying Show less