Industry Sponsored Global Product Safety & Pharmacovigilance Fellowship, UNC/United Therapeutics

Company: Eshelman School of Pharmacy, University of North C
Location: Chapel Hill
Posted on: January 7, 2021

Job Description:

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/ The application deadline for early consideration is October 30, 2020. The final deadline to apply is December 15, 2020. See http://pharmacydpetfellowships.web.unc.edu/ for instructions on submitting an application. Start date: July 1, 2021

Keywords: Eshelman School of Pharmacy, University of North C, Chapel Hill , Industry Sponsored Global Product Safety & Pharmacovigilance Fellowship, UNC/United Therapeutics, Other , Chapel Hill, North Carolina