Senior Manager Pharmacovigilance Operations

• Supervision of a team of Literature Specialists responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS
• Establish and maintain governance frameworks for literature review, search strategy management, quality and compliance oversight, systems and operational support
• Ensure consistent achievement of internal/external SLA/TAT commitments
• Oversee workflow management, mailbox operations, ancillary activities
• Monitor and optimize queue volumes and ageing, productivity and utilization, vendor performance
• Oversee quality framework including QC processes and error monitoring, CAPA management and closure, trend analysis and risk mitigation
• May perform retrospective quality checks on the quality of the literature review performed by team
• Business process owner for global literature review process and literature management systems
• Drive initiatives to improve throughput and cycle time, optimize cost and resource utilization, reduce manual effort through automation
• Lead cross-functional improvement programs
• Represent literature operations in global governance forums and leadership discussions
• Lead and develop a multi-tier team
• Ensure appropriate training and qualification of staff, succession planning and capability building
• Foster a high-performance, quality-focused culture
• Maintain quality metrics to ensure quality of literature review performed by team
• Triage queries from case management and Therapeutic Area Safety
• Oversight of literature review team responsible for routine review of literature articles as part of global literature surveillance process
• Identifies process gaps and proposes process improvement solutions
• Collaborate with local offices to ensure seamless local and global literature process handoffs
• Participate in technology and process improvement projects related to literature surveillance
• Responsible for ownership of literature review process related procedures, training documents, deviation management, and audits/inspections
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support audit and inspection deliverables

• Bachelor's or Master's degree and 14 years of pharmaceutical, biotech or regulatory authority experience or relevant experience in a research and development setting
• Health Care/Life Sciences Professional with minimum 12 years of relevant work experience including 5 years of experience in people management
• Extensive people management experience
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Understands and interprets data/information and its practical application
• Excellent English written/oral communication, and strong time and project management skills
• strategic mindset, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations
• Demonstrate knowledge of global aspects of pharmacovigilance
• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
• Ability to effectively manage competing priorities and timelines
• Strong leadership skills, independence, networking and influencing skills
• Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault
• Strong knowledge of literature citation management systems and platform used to configure search strategies
• Ability to receive feedback from Case Management and Therapeutic Area Safety to optimize quality of literature review

Experience in use of AI and prompts would be useful