Global Patient Safety and Pharmacovigilance
This program includes Butler University, Eli Lilly and Company, and The Office of Medication Error Prevention and Risk Management (OMEPRM) at the USFDA. This program will have one (1) position available for a two-year term (July 2021 through June 2023).
Fellows will begin with the academic sector at Butler University from July–October 2021. They will then move into the industry sector, working with Eli Lilly and Company from November 2021–October 2022. Finally, fellows will learn from the regulatory sector, partnering with the Food and Drug Administration from November 2022–June 2023.
Fellowship Sites:
Butler University College of Pharmacy and Health Sciences
Located in Indianapolis, Indiana, Butler University is a nationally recognized university with six academic colleges. In 2020, Butler was ranked as the top regional university in the Midwest by U.S. News & World Report, the most innovative among Midwest Regional Universities. At the Butler University College of Pharmacy & Health Sciences, you will find a community of health professionals committed to excellence. Our programs prepare students and post-graduate learners to become leaders in their chosen fields. Butler University College of Pharmacy and Health Sciences has a variety of post-graduate residencies and fellowships, each designed to strengthen not only the professionals’ specialty expertise, but also enhance teaching abilities in the classroom through faculty direction and mentorship.
Butler University College of Pharmacy and Health Sciences
4600 Sunset Avenue
Indianapolis, IN 46208
Eli Lilly and Company
For more than 140 years, Lilly has worked tirelessly to develop and deliver trusted medicines that meet real needs. Their growing portfolio of medicines includes treatments in the areas of bone muscle joint, cancer, cardiovascular, diabetes, endocrine, immunology, neurodegeneration, neuroscience, and pain. Lilly's Global Patient Safety organization, consisting of more than 300 physicians, pharmacists, nurses and other health care professionals are dedicated to the collection, monitoring, evaluation and reporting of safety information through the science of pharmacovigilance.
Eli Lilly and Company
893 Delaware St
Indianapolis, IN 46225
United States Food and Drug Administration
Office of Medication Error Prevention and Risk Management (OMEPRM) includes Division of Medication Error Prevention and Analysis (DMEPA) and Division of Risk Management (DRISK). DMEPA looks to minimize medication errors in the U.S. healthcare system. As part of the FDA preapproval process for new drug products, we review proposed proprietary drug names, container labels and other labeling, packaging, product design, and human factors protocols and study results to prevent medication errors. We also monitor and analyze medication error reports for marketed products to determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. DRISK reviews all proposed REMS, REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards.
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993