The Medical Product Safety and Pharmacovigilance curriculum prepares individuals to work with pharmaceutical, biologic, and medical device companies to monitor, track, and report product safety data during ongoing clinical trials, as well as after a product has been approved and marketed.
Course work includes in-depth study of federal regulations, components of a safety monitoring program, and procedures for reporting safety data. Supervised fieldwork focuses on reviewing adverse reports, writing safety case narratives, and creating safety reports in accordance with U.S. and international regulations.
Graduates of this program may be eligible to sit for national certification examinations. Employment opportunities may include medical centers, hospitals, pharmaceutical, medical device, biotechnology companies and contract research organizations.
This program is based upon work supported in part by the North Carolina Biotechnology Center.