SeniorManager,DrugSafetyOperations

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness. The Senior Manager, Drug Safety Operations – DSPUS leads pharmacovigilance operations and compliance for the Americas and Rest of World, ensuring adherence to global and local regulations, primarily for Blue Earth Diagnostics Inc. The role oversees safety processes such as case management, regulatory reporting, and vendor coordination, while maintaining inspection readiness and supporting audits. **Job Purpose** The Senior Manager, Safety Operations – DSPUS is in responsible for overseeing pharmacovigilance operational and compliance activities for the Americas and ROW regions, ensuring full and continuous compliance with global and local regulatory requirements with a primary focus on Blue Earth Diagnostic Inc. The role provides operational governance, compliance oversight, and strategic coordination of safety operations, acting as a key interface between DSPUS, global CDSP functions, Corporate PV Quality Systems, affiliates, distributors, and third‑party partners. . **Main Responsibilities, Activities, Duties, and Tasks** * Provide senior oversight of pharmacovigilance operational activities within DSPUS, including case management, submissions, reconciliations, and safety data management. * Ensure timely and compliant processing and reporting of ICSRs to Health Authorities (e.g., FDA, Health Canada, NMPA, etc.) and business partners. * Oversee operational performance and workload distribution within the DSPUS organiz