At BeyondSpring Pharmaceuticals, I directed global pharmacovigilance operations across the oncology portfolio, establishing governance processes to advance compound, medical, and patient safety across Phase 3 programs. I also reviewed Individual Case Safety Reports and conducted benefit-risk evaluations to identify safety signals and inform risk management.
I led Expanded Access Programs and Investigator-Initiated Studies, and created and reviewed NDA submission documents, including Clinical Study Reports and Risk Management Plans. Earlier, as a Physician Informaticist at American Medical Informatics, I supported clinical adoption and optimization of Cerner and Epic EHR systems.
