Natalie O'Donnell, BSN RN
Corporate Vice President, REMS, Safety and Strategic Engagement
Mrs. O’Donnell leads the UBC REMS SERRM team that develops REMS strategies, develops REMS and REMS Supporting Documents and leads the REMS evaluations.
Mrs. O’Donnell’s background includes more than 20 years of healthcare and clinical research experience and has worked in the area of Risk Management for the last 10 years. Her career began as a registered nurse in the hospital setting where she was responsible for medical surgical patients, pediatric patients, and was a certified oncology nurse. Mrs. O’Donnell’s also spent 2 years as Acute Dialysis nurse, providing renal care to the critically ill. She began in clinical research as a drug safety associate focusing on medical and legal review of medical charts. Then she spent several years in Strategic Research & Marketing where she researched and evaluated the drug development pipeline for major pharmaceutical and biotech companies for a large contract research organization, assisted in the writing and coordination of government proposals, and was responsible for global information requests.
During her tenure she was awarded the Strategic Research and Marketing award.
During her time at UBC Mrs. O’Donnell has overseen pregnancy registries, investigator-initiated studies, and minority focused phase IV trials. While in Program Management, she provided support and direction to UBC project teams conducting late stage studies, including regulatory mandated programs and observational studies.
As the Corporate Vice President, REMS, Safety and Strategic Engagement, she is responsible for UBC Pharmacovigilance, designs REMS, REMS Supporting Documents, REMS tools and oversees the team responsible for REMS effectiveness assessments as well as REM’s FDA Assessment Reports. She ensures quality and performance expectations are being met, including responsibility for detailed timeline development and maintenance, budget management, regulatory requirements, and study start-up and operations
Mrs. O’Donnell received her Bachelor’s of Science in Nursing from the former College Misericordia (currently Misericordia University) in northeastern Pennsylvania followed by her Program Management Certificate from Villanova University, also in Pennsylvania.