Sonia Hernandez-Diaz, M.D., Dr.P.H. a physician and epidemiologist, is the Director of the Pharmacoepidemiology Program and Professor of Epidemiology at the Harvard T.H. Chan School of Public Health. Her area of interest is drug safety evaluation from non-randomized data, with a special emphasis on the design, conduct, and analysis of studies in pregnant women and their infants. She has experience developing and applying methods to case-control surveillance, case-only, and ad hoc pregnancy cohorts (registries) study designs. In collaboration with colleagues at Brigham and Women’s Hospital, she has identified a cohort of more than 2 million low income pregnant women ascertained in the Medicaid Analytic eXtract (MAX) database. She has implemented similar methods to identify cohorts of mothers linked to infants within an US nationwide commercial claims insurance administrative database (IBM MarketScan Data) and Electronic Medical Records from the UK (THIN). Current projects include the identification of nested pregnancy cohorts exposed to specific medications within multinational health care data pooled from five Scandinavian National Registers and the US, the International Pregnancy Safety Study (InPreSS). Examples of her work include inquiries of the comparative safety of antiretroviral therapy regimes, psychotropics, antiepileptic drugs and opioids for pregnant women and their offspring.
Hernandez-Diaz has published more than 270 articles in respected clinical and epidemiological journals. She is Past-President of both the International Society for Pharmacoepidemiology and the Society for Perinatal and Pediatric Epidemiology Research; and has served as a Special Government Employee for the FDA Drug Safety and Risk Management Advisory Committee (current Chair), as a member of the NICHD Pregnancy & Neonatology (PN) Study Section, and as member of the Teratogenic Information Services (TERIS) Advisory Board. She was a scientific advisor for SAMHSA to write “A Guide to the Management of Opioid-Dependent Pregnant and Parenting Women and Their Children” and a member of the CDC Steering Committee for the “Treating for Two; Safe Medication Use in Pregnancy” Initiative. Through her service to public health institutions she has contributed to the translation of research into policy and actionable recommendations for stakeholders.