United Therapeutics Global Drug Safety/Pharmacovigilance Fellowship
- Application deadline: January 1
- Length: Two years
This postdoctoral fellowship at United Therapeutics Corporation provides practical training and experience in key Global Drug Safety/Pharmacovigilance (GDS/PV) functions in order to gain expertise in the GDS/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 GDS/PV practitioner prepared to launch a successful and impactful career in GDS/PV within the pharmaceutical industry.
The ideal candidate should possess a nimble and dexterous approach, demonstrated analytic ability, strong communication skills, and substantial leadership experience.
Fellows will engage in didactic instruction and clinical research projects that supplement training and professional interests to gain a complete understanding of the drug development process and the role of GDS/PV within that process. Fellows will be exposed to cross-functional collaboration and regulatory research requirements for investigational and marketed drugs. During the first year of appointment, fellows participate with faculty at the UNC Eshelman School of Pharmacy to advance clinical research and drug safety initiatives. The second year is comprised of preceptorship from members of the GDS/PV group at United Therapeutics to receive hands-on training and become integrated into a product timeline.
Program Goals and Objectives
- Understand the mission of a pharmacovigilance department and the role of GDS/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.
- Integration 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 health 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.
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. Currently, the company’s revenue-generating products are all in the field of cardiovascular medicine. While building business value in the cardiovascular field, the company is also laying important foundations for future franchises in the treatment of cancer and infectious diseases.
Associate Director, Clinical Fellowship Programs
3201 Kerr Hall, CB# 7569
Visit http://pharmacydpetfellowships.web.unc.edu/ for instructions on submitting an application.
Early Consideration: November 15
Final: January 1
After you apply, you will receive a confirmation email once your application has been submitted. Following review, you may be invited to interview at UNC and on-site with fellowship sponsors. Fellowship interviews begin in early January and typically conclude in March. You will be notified of the final disposition of your application as soon as possible.
Information interviews may be arranged for the ACCP Annual Meeting and the ASHP Midyear Clinical Meeting. Potential candidates are encouraged to attend these meetings to meet with UNC faculty, fellows, alumni, and sponsors. We also encourage you to register for the Midyear Personnel Placement Service.