- Maria DeMattie
- Associate Director, Lean Sigma Black Belt, PV Scientist, Global Pharmacovigilance & Epidemiology
- Bristol-Myers Squibb
Maria’s 14 years of pharmacovigilance (PV) experience includes core signal detection, managing Medical Surveillance Teams (MST), responding to Health Authority safety data queries, authoring regulatory reports, and contributing to various Health Authority inspection-related activities. Maria leads cross-functional Safety Data Review (SDR) Teams, and participates in related PV and product-development sub-teams in specified therapeutic areas. She is also the Operational Chair of the BMS Pharmacovigilance Safety Science forum which is a decision-making body focusing on key safety science issues, including signal assessment findings, safety science innovation, and risk management strategy.
Maria is a certified Lean Six Sigma Black Belt and BMS certified Kaizen Leader. She has been the project leader for multiple continuous improvement projects across the BMS organization, to develop and implement innovative processes to create efficiencies while meeting the changes in regulatory requirements. Her latest project focuses on a robust and powerful visualization tool designed to enhance signal detection capabilities at BMS, to help product experts proactively detect signals, characterize them rapidly, identify key cases for detailed review, and to monitor trends.
Maria is a dynamic speaker and a recipient of multiple BMS recognition awards including the Global Regulatory & Safety Sciences Distinction Award. As a trained RN for cardiac critical care, surgical and recovery care, and hemodialysis, Maria is committed to patient care and safety.