Director / Associate Director, Global Patient Safety | Pharmacovigilance | Drug Safety Physician

Lead global pharmacovigilance and patient safety activities supporting advanced therapy and clinical development programs. Provide medical oversight for safety surveillance, signal evaluation, aggregate reporting, and adverse event assessment. Partner with Clinical Development and Regulatory Affairs to execute product safety strategies throughout the lifecycle. Support inspections, audits, vendor oversight, and continuous process improvement initiatives. Manage department staffing, training, development, performance reviews, and staff meetings.

Directed global patient safety strategy for allogeneic cell therapy development programs. Chaired Safety Management Teams and led cross-functional signal detection and risk management activities. Authored and reviewed aggregate safety reports, regulatory responses, and core safety documents. Developed Risk Management Plans, Investigator Brochures, and product labeling content.

Led signal detection, safety trend analysis, and benefit-risk evaluations across development and marketed products. Performed medical review of SAEs, narratives, and safety datasets supporting regulatory decisions. Supported REMS, RMPs, labeling updates, SOP development, CAPAs, and inspection readiness. Organized and prepared safety data for quarterly Safety Management Team meetings and drafted meeting minutes.

Conducted medical review of safety cases for investigational and marketed products. Authored and reviewed DSURs, PBRERs, PSURs, and PADERs. Contributed to safety signal evaluation, benefit-risk assessments, and global regulatory compliance.

Provided inpatient, outpatient, and emergency medical care while maintaining high standards of patient safety.