Senior Manager, Drug Safety Operations

Job Purpose The Senior Manager, Safety Operations – DSPUS is 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 ICSR to Health Authorities (e.g., FDA, Health Canada, NMPA, etc.) and business partners. Oversee operational performance and workload distribution within the DSPUS organization and across vendors or partners, as applicable. Supervisory Responsibilities Not Applicable Education University degree in Pharmacy, Pharmaceutical Chemistry and Technology, or a related scientific discipline. Professional Experience, Knowledge & Technical Skills At least 5 years of experience in pharmacovigilance, preferably in a multinational and matrixed organization. Knowledge of pharmacovigilance regulations (GVP, FDA, EMA, ICH). Able to organize, prioritize, and work effectively in a constantly changing environment. Excellent oral & written communication skills in English. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities. Strong organizational skills; team player. Experience and skills with cross‑functional and highly matrixed organizations. Core Relationships Effective interaction and coordination with other Drug Safety staff, as well as personnel from other departments within Medical and Regulatory Affairs (Medical Affairs & Scientific Information, Clinical Research, Biometrics and Medical Writing, Medical Planning and Management, Regulatory) to assure regulatory compliance and support drug safety related activities. Interacts with Information Technology Services. Interacts with Corporate Quality Management and BDI Quality Operations. Interacts with appropriate Legal Department (when applicable). Operational contact with distributors, partners, and affiliates for PV-related activities. Work Environment The employee must be able to communicate via telephone, written correspondence, or spoken word in order to perform the essential duties of the position. Bracco Diagnostics Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or any other protected status. #J-18808-Ljbffr Bracco Imaging