Program Overview

Medical Product Safety and Pharmacovigilance - Certificate

A male Durham Tech student points with a pen in his right hand to an EKG chart held by the EKG class instructor.
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 12. 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 (available here February 1, 2020).

Next Application Deadline is Jul 12

Estimated Tuition & Fees

$1292.00

Location

Online

Credit Hours

17

Program Stats

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Average Salary

$25,000-$35,000
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Average Class Size

16
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Estimated Completion Time

8 months

Current and Upcoming Course Offerings

Course Number Title Credit Hours
MSP-110 Introduction to Medical Product Safety 3
MSP-220 Signal Detection and Risk Assessments 4