Accomplished pharmacovigilance professional with approximately 20 years of experience spanning vendor and sponsor roles, with expertise in safety monitoring and operations across clinical trials, regulatory approvals, labeling, commercial use, and registry set-up. I have led teams, served as lead PV scientist for two gene therapy approvals, supported FDA interactions including the first advisory committee for a gene therapy for beta-thalassemia, and led commercial gene therapy programs with ongoing clinical development. My career includes roles at Ironwood Pharmaceuticals, Biogen, bluebird bio, and Beam Therapeutics, and I remain deeply committed to advancing pharmacovigilance and ensuring patient safety.