Michael Oghani

I’m a Physician and Global Patient Safety leader with 11+ years of experience in pharmacovigilance, clinical safety, and benefit-risk assessment. I focus on safety governance, signal detection and management, and regulatory safety strategy across biotechnology and pharmaceutical organizations—especially oncology and cell & gene therapy programs.

As Medical Director, Global Patient Safety at Legend Biotech, I lead global pharmacovigilance and patient safety activities supporting advanced therapy and clinical development programs. I provide medical oversight for safety surveillance, signal evaluation, aggregate reporting, and adverse event assessment, partnering with Clinical Development and Regulatory Affairs to execute product safety strategies across the lifecycle.

At Allogene Therapeutics, I directed global patient safety strategy for allogeneic cell therapy development programs and chaired Safety Management Teams to drive cross-functional signal detection and risk management. I authored and reviewed aggregate safety reports and regulatory responses, developed Risk Management Plans, Investigator Brochures, and labeling content, and supported patient management and managed care initiatives through utilization reviews and prior authorizations.

Earlier roles strengthened my end-to-end expertise in medical review and regulatory-ready safety documentation, including SAEs, narratives, safety datasets, and DSUR/PBRER/PSUR/PADER reporting. Across Axsome Therapeutics and Global Blood Therapeutics, I supported REMS and RMPs, labeling updates, SOP development, CAPAs, inspection readiness, and health authority interactions—always with a data-driven, quality-focused approach to safety.