Dawn Long

Dawn Long is an accomplished pharmacovigilance executive with more than 25 years of leadership experience across clinical and post-marketing safety, regulatory compliance, global operations, and systems integration. With a strong background in nursing and pharmaceutical law, she has successfully led drug safety strategies across the biotech, pharmaceutical, and non-profit sectors.

Currently, Dawn serves as the Pharmacovigilance Operational Leader at the Gates Medical Research Institute, where she oversees PV systems, safety reviews, and outsourcing strategies for clinical trials conducted in LMIC settings. Previously, she held the role of Executive Director at Paratek Pharmaceuticals, where she led global pharmacovigilance and risk management efforts. Her work included negotiating safety agreements with development and marketing partners and ensuring regulatory compliance for both marketed and investigational products in infectious diseases.

Prior to her work at Paratek, Dawn was the GCSP Regions Lead for the Americas at CSL Behring, where she led country-level Safety Officers across Canada and the Americas. In this role, Dawn worked closely with QA on compliance audits of pharmaceutical manufacturers and distributors in the regions.

From 2002 to 2015, Dawn was a key member of the pharmacovigilance leadership team at Shire Pharmaceuticals. She chaired the Executive Safety Review Committee and the R&D Operating Committee for years. During her tenure, Dawn led PV integrations for multiple company mergers and acquisitions. She directed cross-functional safety teams in neuroscience, rare diseases, and internal medicine, supporting regulatory submissions. Her work has consistently advanced global safety oversight, improved regulatory submission processes, and optimized vendor and partner management.

Dawn holds a Master of Science in Jurisprudence from Seton Hall Law School and a Bachelor of Science in Nursing from Northeastern State University.