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 PurposeThe 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 organization and across vendors or partners, as applicable.
- Ensure continuous compliance of DSPUS safety activities with:
- Global and local regulatory requirements
- Internal SOPs, Working Instructions, and PV Agreements
- Involved in :
- Common mailbox oversight (BED and DSPUS)
- Reconciliations
- PADER and PSUR/PBRER Appendix preparation (when applicable)
- Contractual and PVA preparation
- Actively support PV audits and regulatory inspections for BED, including:
- Inspection readiness activities
- Participation in audits/inspections
- Management of inspection outcomes and follow-up actions
- Ensure DSPUS operational activities remain inspection-ready at all times.
- Contribute to the continuous improvement of the Pharmacovigilance Quality System through trend analysis, metrics, and feedback to Corporate functions.
- Serve as a key operational and compliance interface with:
- Corporate Pharmacovigilance Quality Systems & Risk Management
- Global Risk Assessment (GRA)
- Safety Systems / IT
- Regulatory Affairs, Medical Affairs, Clinical, and other cross-functional stakeholders
- Coordinate PV-related activities with distributors in the Americas and ROW regions.
- Act as a DSPUS escalation point for complex operational and compliance issues.
Supervisory Responsibilities 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 to 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 EnvironmentThe employee must be able to communicate via telephone, written correspondence, or spoken word in order to perform the essential duties of the position.
