United Therapeutics Global Drug Safety/Pharmacovigilance Fellowship
This fellowship is sponsored in collaboration with United Therapeutics Corporation, and is part of the DPET fellowship program.
- Application deadline: December 15, 2020
- Length: Two years
United Therapeutics Corporation, in cooperation with UNC Hospitals and the UNC Eshelman School of Pharmacy, sponsors a two-year fellowship in Global Product Safety and Pharmacovigilance (GPS & PV). This program offers an innovative combination of pharmacovigilance, medication-use safety and policy, and didactic training that is not offered by any other pharmacovigilance post-doctoral fellowship program. This fellowship is designed to provide practical training and experience in translatable medication safety work within the Hospital and in key GPS & PV functions, to develop a practitioner with a broad understanding of how their work in the pharmaceutical industry impacts medication use in a clinical setting. As with traditional pharmacovigilance fellowships, the fellow will be fully trained in the GPS & PV requirements of drug development and investigational and marketed product risk management and surveillance in order to launch a successful and innovative career in GPS & PV in the pharmaceutical industry.
During the first year of appointment, fellows participate with Pharmacy leaders in Medication Safety and Medication-Use Safety & Policy at UNC Hospitals to advance Drug Safety initiatives and Management. This year will utilize a layered learning approach, where the fellow will collaborate with a post-graduate year two (PGY2) resident in Medication-Use Safety & Policy, as well as pharmacy students and pharmacy student interns. Didactic training in medication safety and regulatory affairs will be required, with additional coursework available given fellow time and interest. The second year is comprised of preceptorship from members of the GPS & PV group at United Therapeutics Corporation to receive hands-on training to gain a complete understanding of the drug development process and the role of GPS & PV within that process. Fellows will be exposed to cross-functional collaboration and regulatory research requirements for investigational and marketed drugs. A layered learning approach will be provided this year, as well, with pharmacy students on rotation.
Fellows will develop expertise in:
- Aggregate data analysis
- Signal detection
- Benefit-risk evaluation and risk mitigation strategies
- International regulatory requirements, specifically as it applies to drug safety
- Clinical medication safety
- Project management
- Medical writing
Program Goals and Objectives
- Understand the mission of a pharmacovigilance department and the role of GPS & PV in clinical development and product lifecycle management.
- Work effectively with different 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.
- Develop a working knowledge of global governing safety guidelines, regulations, and internal standard operating procedures.
- Enhance 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 heath authorities including the Periodic Benefit Risk Evaluation Report (PBRER) and Developmental Safety Update Report (DSUR).
- Prepare manuscripts that further elucidate the safety profile of investigational and marketed products.
- Develop strategic thinking ability with a global pharmacovigilance and regulatory perspective.
The ideal candidate should possess an innovative and entrepreneurial spirit, demonstrated analytic ability, strong communication skills, and substantial leadership experience.
About United Therapeutics Corporation
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. The company’s currently marketed products are in the field of rare diseases: pulmonary arterial hypertension and neuroblastoma. In addition, the company, through a wholly-owned subsidiary, is focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply.
Visit http://pharmacydpetfellowships.web.unc.edu/ for instructions on submitting an application.
· Early Consideration: October 30, 2020
· Final: December 15, 2020
After you apply, you will receive a confirmation email once your application has been submitted. Following review, you may be invited to interview with UNC and fellowship sponsors. Fellowship interviews begin in early December and typically conclude in January. You will be notified of the final disposition of your application as soon as possible.
Informational interviews may be arranged for the ACCP Annual Meeting and the ASHP Midyear Clinical Meeting. These meetings will be held virtually this year. Please continue to check the website for further details.
Associate Director, Clinical Fellowship Programs
3201 Kerr Hall, CB# 7569