Pharmacovigilance Operations Senior Manager

The Pharmacovigilance Operations Senior Manager provides strategic leadership and operational oversight of the global safety system and associated data mart to ensure accurate, compliant, and timely safety data analytics and reporting.

Requirements

• Provide leadership and oversight for changes, enhancements, and configurations of the global safety system and associated data mart.
• Own data integrity, consistency, and reliability standards for safety data used in analytics, regulatory submissions, and decision-making.
• Direct and govern User Acceptance Testing (UAT) activities to ensure validated, inspection-ready system changes.
• Oversee system configurations, including reporting rules, product and study setup, and integration points.
• Partner with Safety Technology and Managed Services to optimize system performance, support models, and service delivery.
• Own the strategy, prioritization and delivery of safety data outputs supporting: Periodic safety reporting (e.g., PADER, PSUR, DSUR), Signal detection and safety surveillance & Regulatory inquiries, audits, and inspections
• Ensure timely, high-quality delivery of automated and scheduled safety reports.
• Establish quality oversight, peer review standards, and continuous improvement for safety data outputs.
• Lead the definition and implementation of reporting solutions, including: User-defined reports, Query By Example (QBE) & Optimized search strategies aligned with global standards
• Translate business requirements into scalable, compliant reporting solutions.
• Provide strategic oversight for study start-up and integration activities, including: EDC–Safety Database integrations (e.g., RAVE/Veeva to LSMV/Argus)
• Review and approval of Mapping Specifications Worksheets (MSWs)
• UAT planning, execution, and documentation
• Ensure integrations meet regulatory, validation, and data quality expectations.
• Define and drive the roadmap for automation, AI, and advanced analytics within pharmacovigilance operations.
• Lead the evaluation, implementation, and validation of innovative technologies, including: AI-assisted case processing, Signal detection and analytics solutions & Reporting and workflow automation
• Partner cross-functionally to pilot and operationalize new capabilities while ensuring compliance, data integrity, and inspection readiness.
• Monitor emerging technologies, industry trends, and regulatory expectations related to AI in pharmacovigilance.
• Establish governance, documentation, and change management frameworks to ensure sustainable and compliant adoption of innovation.
• Lead the development and delivery of training for safety systems, reporting tools, and associated processes.
• Drive process standardization and continuous improvement through SOPs, work instructions and user documentation.
• Mentor and develop team members, strengthening technical depth and leadership capability.
• Execute activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as defined in the PV System Master File.
• Maintain a continuous state of inspection readiness across systems, data, and processes.
• Serve as a primary representative for: Health Authority inspections, Internal and external audits
• Own audit responses and remediation activities within scope of responsibility.