Marguerite Brackley

Independent Consultant
Marguerite Brackley

Education

M.D., University of Massachusetts Medical School

Summary of Experience

Dr. Brackley is board certified in internal medicine and an expert in patient and medical safety. Her deep knowledge of clinical trial management includes clinical events committees and safety event reviews, as well as pharmacovigilance, post-market processes, field actions, and risk management. She has consulted on these issues to medical device, diagnostic, and pharmaceutical companies for over a decade. Dr. Brackley’s expert experience includes providing medical insight, post-market surveillance, and pharmacovigilance expertise in complex legal matters, in which she has submitted expert reports and testified at deposition; supporting legal teams in their review and understanding of complex medical and epidemiological issues; and reviewing medical records, complaints, and regulatory submissions. She has provided safety oversight and medical review expertise in clinical studies, and developed processes for clinical trial adjudication and data safety monitoring boards. In addition, Dr. Brackley has created strategies for developing and optimizing medical safety groups in the medical device, diagnostic, and pharmaceutical industries, including processes, procedures, organizational structure, implementation, and rollout. Earlier in her career, as a vice president and medical safety officer at Boston Scientific, she provided safety oversight and safety vigilance throughout the product life cycle and was involved in strategic decision making across all products worldwide. Prior to her roles in industry, Dr. Brackley completed a residency in internal medicine. She is a member of the American Medical Association, the Massachusetts Medical Society, and the Regulatory Affairs Professionals Society.

AG Contacts

Mei Sheng Duh
Brian Ellman