What are the responsibilities and job description for the Senior Manager Drug Safety position at Bracco Imaging?
The Senior Manager, Safety Operations – DSPUS leads pharmacovigilance operations and compliance, with a primary focus on supporting Blue Earth Diagnostics Inc. This role is responsible for ensuring full adherence to global and local safety regulations while driving operational excellence.
You will serve as a key liaison across global safety functions, corporate quality systems, affiliates, distributors, and external partners, helping maintain a robust and compliant pharmacovigilance system.
Key Responsibilities
- Oversee pharmacovigilance operations, including case management, submissions, reconciliations, and safety data management
- Ensure timely and compliant reporting of ICSRs to global health authorities (e.g., FDA, Health Canada, NMPA) and business partners
- Monitor operational performance and manage workload distribution across internal teams and external vendors
- Maintain ongoing compliance with global and local regulations, SOPs, and pharmacovigilance agreements
- Support audit and inspection readiness, including participation and management of follow-up actions
- Contribute to continuous improvement of pharmacovigilance quality systems through metrics, trend analysis, and feedback
- Partner cross-functionally with Regulatory Affairs, Medical Affairs, Clinical teams, IT, and Risk Management
- Coordinate pharmacovigilance activities with distributors and partners across the Americas and ROW
- Act as an escalation point for complex safety operations and compliance issues
Qualifications
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline
- Minimum of 5 years of pharmacovigilance experience, preferably within a global, matrixed organization
- Strong knowledge of pharmacovigilance regulations (GVP, FDA, EMA, ICH)
- Excellent verbal and written communication skills
- Proven ability to manage competing priorities in a fast-paced environment
- Strong organizational skills with a collaborative, team-oriented mindset
- Demonstrated ability to influence stakeholders and build credibility across diverse teams