Hewei Li
About Hewei Li
Hewei Li is the Associate Medical Director of Global Pharmacovigilance at Bristol-Myers Squibb in New York, with over 30 years of experience in clinical medicine, clinical research, drug development, and pharmacovigilance.
Company
Hewei Li currently serves as the Associate Medical Director, Global Pharmacovigilance at Bristol-Myers Squibb. Located in New York, New York, United States, Bristol-Myers Squibb is a well-known biopharmaceutical company focused on discovering, developing, and delivering innovative medicines. In this role, Li is involved in ensuring the safety and efficacy of the company's products through rigorous pharmacovigilance practices.
Previous Experience at BD
Hewei Li worked at BD as a Principal Scientist from 2000 to 2006. During his six-year tenure, Li focused on advancing scientific research and contributing to significant projects within the company. BD is a leading global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents. His role as Principal Scientist would have involved extensive research and development efforts, laying a strong foundation for his future endeavors in the field.
Education and Expertise
Hewei Li holds both an MD in Internal Medicine & Pathology and a PhD in Molecular Biology & Molecular Pathology. This dual educational background has equipped him with a robust understanding of both clinical and molecular aspects of medicine. Coupled with over 30 years of combined experience in clinical medicine, clinical research, drug development, and pharmacovigilance, Li is well-versed in the complexities of the medical and pharmaceutical industries.
Global Pharmacovigilance Leadership
Hewei Li has over 12 years of hands-on expertise in global pharmacovigilance leadership, specifically in the therapeutic areas of immuno-oncology, oncology, and immunology. His specialized skills include drug safety signal detection and refining, benefit-risk assessment, risk management and mitigation, safety profile characterization, and aggregate safety reporting. Li's leadership in these areas ensures that the medical products under his supervision maintain high standards of safety and efficacy.
Regulatory Engagements and Submissions
Hewei Li has engaged with health authorities and contributed to numerous Investigational New Drug (IND) and Biologics License Application (BLA) submissions, resulting in successful approvals. His experience in regulatory engagements ensures that new medical products comply with stringent regulatory standards, enabling their progression from development to market. This aspect of his career highlights his critical role in the development and approval of new therapies.