Experienced professional with over 15 years of expertise in literature surveillance, quality oversight, and regulatory compliance with top-tier pharmaceutical environments. Proven ability to lead end-to-end literature surveillance process, develop and optimize search strategies and manage diverse product portfolios with a strong focus on data accuracy and inspection readiness. Adept at driving quality initiatives. Recognized for strategic problem solving, cross functional collaboration, and building team capability through training, mentoring and continuous process improvement. Awarded for process efficiency and change management excellence at GSK. Currently managing literature surveillance with a proactive, detail oriented and impact driven approach.
Oversaw and scheduled operational activities within Pharmacovigilance (PV) projects, ensuring timely and accurate delivery in compliance with regulatory and project specific requirements.
Served as a Subject Matter Expert (SME) to cross-functional teams offering guidance on case processing workflows, documentation standards and best practices.
Led the Training and mentoring of junior team members, enhancing team capability and ensuring consistent adherence to quality standards and SOPs.
Contributed to literature surveillance activities including literature screening, reconciliation and documentation in alignment with sponsor requirements. Supported reconciliation process to ensure clean handoffs and inspection readiness.
Scientific and literature curation, screening , bibliographic indexing, analysis and interpretation of key scientific data from international publication, editorials, commentaries and clinical trial databases.
Abstract preparation and report writing of medical and clinical data.
Data validation.
Training and mentoring.
Literature Surveillance
Periodic Reports
Risk management
Search Strategy
Signal Detection
Case management