A male Durham Tech student points with a pen in his right hand to an EKG chart held by the EKG class instructor.

Contact

Sharleen Traynor
Director/Instructor
Tech (Building 9), room 230A
919-536-7200, ext. 8121
traynors@durhamtech.edu

Admissions Questions

Stephanie L. Toomer
Admissions Counselor
toomers@durhamtech.edu
919-536-7200, ext.1119

Plan of Study

(Courses by Semester)
* This program can be completed online.

Medical Product Safety and Pharmacovigilance - Certificate

Short Term

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.

Before you Apply

View the Admissions Checklist. Attend an information session (recommended). The are listed in the Upcoming Events section below.

Apply to the College

New students who are not currently enrolled at Durham Tech should apply to the College using the Health Tech Students then Steps to Apply.

Apply to the Program

Complete the Medical Product Safety and Pharmacovigilance Certificate program application.

Submit program applications electronically to Admissions, Registration, and Records (not Health and Wellness). Drop off locations are also listed on the Electronic Document Submission webpage.

Estimated Tuition & Fees

$1,299

Location

Online

Credit Hours

17

First-Semester Courses

Course Number Title Credit Hours
MSP-110 Introduction to Medical Product Safety 3

Suggested Paths

Long Term

(More than 12 months)

University Transfer