Marie Liles-Burden | Director, PV Risk Management
Takeda

Marie A. Liles-Burden, MPH, is a pharmacovigilance and risk management leader with more than 15 years of experience in global drug safety, benefit-risk assessment, and regulatory risk management. She currently serves as Director of Pharmacovigilance Risk Management at Takeda, where she provides strategic leadership for global risk management programs, including Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional risk minimization measures (aRMMs). Her work focuses on translating complex safety data into actionable risk management strategies that support patient safety and regulatory compliance worldwide. 
 
Marie has authored and co-authored multiple peer-reviewed publications and scientific presentations on pharmacovigilance, regulatory commitments, patient engagement, and innovative approaches to risk minimization. Her work includes publications in Therapeutic Innovation & Regulatory Science, Drug Safety, and Expert Opinion on Drug Safety, as well as presentations at international forums including DIA, ISoP, and the World Patient Safety Congress. She is particularly interested in advancing patient-centered risk management, strengthening regulatory oversight, and exploring innovative approaches to safety communication and risk minimization.