Associate - Senior Pharmacovigilance Manager (PV systems)

The PV Manager leads safety database oversight, ensuring data quality, regulatory compliance, and system optimization. This role supports reporting, validation, training, and cross-functional collaboration while driving continuous improvement and team mentorship.

Role and Responsibilities

• Lead the development and delivery of complex standard and custom reports to meet evolving regulatory requirements and strategic internal needs.
• Oversee database design, set-up, and configuration, ensuring alignment with protocol and product-specific requirements in collaboration with IT, Safety, and Project Management teams.
• Lead validation efforts for computerized PV systems, maintaining compliance with GxP, 21 CFR Part 11, and other regulatory frameworks.
• Strategically manage data migration activities between legacy and modern safety databases, ensuring integrity, traceability, and completeness throughout.
• Develop and deliver advanced training programs on safety database processes, ensuring smooth onboarding and upskilling across regions.
• Act as a Subject Matter Expert (SME) for safety system configurations supporting global pharmacovigilance processes.
• Oversee Cumulative Data Quality Reviews (CDQRs), and drive proactive data integrity initiatives across safety platforms.
• Drive the creation, implementation, and refinement of SOPs, guidelines, and work instructions pertaining to safety database operations.
• Champion continuous improvement initiatives to optimize database performance, user experience, and compliance posture.
• Collaborate with global cross-functional teams (IT, QA, Regulatory, PV Operations, and Commercial) on system enhancements, issue resolution, and client delivery excellence.
• Provide strategic input and support to the Business Development and Commercial teams for proposals, RFPs, and client engagements, representing safety systems capabilities.
• Mentor and coach junior PV team members, building internal capabilities around safety systems and process excellence.
• Represent the PV Systems function in audits and inspections, and ensure readiness of database-related documentation and processes.