FSP Associate Manager, Safety Data & Systems

Job Title: FSP Associate Manager, Safety Data & Systems Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 1 GENERAL INFORMATION Name of Role: Associate Manager, Safety Data & Systems, GPS Operations Function: Global Patient Safety (GPS) 2 PURPOSE OF THE FUNCTION Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities Provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation Collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations 3 REPORTING LINE Sr. Director Safety Data and Systems, GPS Operations or designee 4 ROLES AND RESPONSIBILITIES Manages and monitors applicable GPS mailboxes including unblinded data Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system. Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing. Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules. Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms. Collaborate closely with the pharmacovigil