Haley Kaplowitz, serves as Executive Director of Safety, Epidemiology, Registries, and Risk Management (SERRM). In this role, Haley provides expertise in product and drug safety, risk management, and pharmacoepidemiology solutions. She is adept at proactively recognizing products that require risk assessment or mitigation strategies. She designs and implements disease and product registries to meet regulatory requirements and address commercial objectives while examining real-world use of drugs and associated outcomes. In addition, Haley communicates product safety issues and risk factors with all involved stakeholders.
Haley is an accomplished epidemiologist with more than two decades of healthcare experience. She is experienced in providing strategic direction and optimizing the use of epidemiological data. Her career includes roles with pharmaceutical manufacturers, such as the Head of Epidemiology and Center for Healthcare Data Analytics and Senior Epidemiologist. As part of a sponsor team, Haley works directly with U.S. and EU regulatory authorities, wrote one of the earliest REMS required and approved by the FDA, and co-led and wrote one of the earliest RMPs to be accepted by EU regulators.
Haley earned a PhD from the University of Texas School of Public Health.