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.
Students are eligible to enroll in the certificate program if they have completed a baccalaureate or graduate degree in biological science, chemistry, or an allied health area, or have completed one year of employment in the clinical research field within the last five years.
How to Apply: Program applications are accepted until July 10. View the Admissions Checklist. Use the button below to apply to Durham Tech following the Health Technologies Enrollment Steps, then complete the Medical Product Safety and Pharmacovigilance program application.
If you have questions about admissions requirements after reviewing the information, you may contact Johanna Brown.