The UNC Eshelman School of Pharmacy, in cooperation with United Therapeutics, sponsors a two-year fellowship in Global Product Safety & Pharmacovigilance.
This postdoctoral fellowship at United Therapeutics Corporation provides practical training and experience in key Global Product Safety & Pharmacovigilance (GPS & PV) function. Expertise will be gained in the GPS & PV requirements of drug development and investigational and marketed product risk management and surveillance. Overall, this program should enhance the knowledge and real-world experience of the fellow and develop a GPS & PV practitioner prepared to launch a successful career in GPS & PV within the pharmaceutical industry.
Fellowship objectives are to provide training and experience in critical aspects of GPS & PV, including:
Understand the mission of a pharmacovigilance department and the role of GPS & PV in clinical development and product lifecycle management;
Work effectively with key functional areas and develop strong communication and project management skills to ensure that projects are approached and carried out efficiently and effectively;
Integrate into the matrix organizational model aimed at achieving a functional and product focus through the sharing of multiple perspectives and effective use of specialized resources;
Gain a working knowledge of global governing safety guidelines, regulations, and internal standard operating procedures;
Develop the ability to critically evaluate, interpret, synthesize, and present safety data through the performance of signal detection analysis and risk characterization;
Prepare high quality, scientifically accurate, safety regulatory documents for submission to health authorities, including the Periodic Benefit Risk Evaluation Report (PBRER) and Developmental Safety Update Report (DSUR);
Prepare manuscripts that fully elucidate the safety profile of investigational and marketed products; and
Develop strategic thinking abilities with a global pharmacovigilance and regulatory perspective.
Fellows will spend the first year of appointment at the University of North Carolina in Chapel Hill under the direction of UNC faculty. The second year of appointment will be spent on location at the fellowship sponsor’s research facilities in the Research Triangle Park, North Carolina. For more information: https://pharmacy.unc.edu/academics/fellowships/utc-gds-p/
Preferred qualifications include a PharmD, PhD, or MD. An advanced degree must be conferred by the time of appointment.
Application requirements: CV, letter of interest, unofficial transcripts, and three professional letters of recommendation.
Additional Salary Information: Compensation includes a standard UNC benefits package, health insurance, support for professional travel and career development.
About Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
At the UNC Eshelman School of Pharmacy, everything we do begins and ends with a patient in mind. We are preparing the next generation of scientists, clinicians and practitioners to discover solutions to the world’s most challenging health care issues. Throughout our history, the School has built a reputation for cutting edge research, rigorous training programs, and outstanding faculty, staff, and students. A world-class university, a model Area Health Education Center (AHEC) system, an award-winning hospital system, and an international center for pharmaceutical research and development, and close proximity to the Research Triangle Park, creates one of the most dynamic centers of learning in the nation. The School is one of five health affairs schools on the campus of the University of North Carolina at Chapel Hill and benefits from close collaborations with many on-campus research programs, including the Carolina Center for Genome Sciences, the Lineberger Comprehensive Cancer Center, the Center for Infectious Diseases, and the McAllister Heart Institute. The School is the number one ranked pharmacy program based on the U.S. News & World Report ranking and is one of the leaders among schools of pharmacy in research funding.