Operators Coordinator Incyte

.Manage the administrative support across all Lifecycle Safety service lines to the SO and LSM functions as appropriate. Provide support to junior administrative team members. Essential Functions Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events (AE) / endpoint information, determining initial / update status of incoming events, tracking timelines for completion of event processing, distributing event information to appropriate project personnel in the workflow for continued processing, review and preparation of endpoint documentation, transfer of events to client and other parties as identified by operations lead, obtaining confirmation of report receipt and track submission and assuming workflow responsibilities for various projects. May assist with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with deadline quality measurements, as directed by operations team member or manager. Assist with administrative team support e.G. project start-up tasks, creation and maintenance of project files, systems access requests, periodic distribution of AE listings, and shipping of information supplies to sites as directed by senior operations team member. May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization holders, investigators, customers and operations team in accordance with deadlines, perform project administrative tasks such as creation of labels using investigator list, maintenance of personal safety files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking and filing of submission dossiers, and distributing listings to client and / or operations team members. Creating, maintain and track case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications / systems as directed. Archiving case folders and project files after event closure, coordination of transfer of archived material to company / customer archive storage facilities after study closure, assisting in creation of records management processes and procedures, providing key input to operations team on acquisition and / or upgrade of records management application / systems and serving as liaison between Lifecycle Safety department and records management department