USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, and Gilead Sciences, Inc. are proud to offer a 24-month Fellowship Program in Patient Safety for two recent doctoral graduates (PharmD, MD, PhD, or equivalent doctorate degree). Patient Safety (PS) is a crucial part of drug development and commercialization to communicate the risks of Gilead’s medicines, so patients can derive the maximum benefit. The Patient Safety Fellowship will be located at our Foster City, CA, campus, and two fellows will be chosen to work with our PS team. There will be occasional travel as required for in-person conferences and meetings. The fellow will be integral to the PS team and will work closely with our PS Scientists and Physicians and Global Safety Leads.
Duration: 2 years (July 1, 2024 – June 30, 2026) Positions Available: 2
Patient Safety Fellowship Activities:
Learn about US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations related to pharmacovigilance practices including:
Regulations related to the reporting of Adverse Events
The preparation of aggregate safety reports such as Development Safety Update Reports (DSUR) and PBRER (Periodic Benefit Risk Evaluation Report)
The development and maintenance of risk management plans (RMPs)
How individual case safety reports are evaluated through observations
Support implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure, and other key safety documents.
Conduct signal detection and evaluation activities for assigned products in collaboration with the Patient Safety Physician and Scientist as part of the continuous benefit-risk evaluation throughout the product lifecycle.
Contribute to safety reviews of adverse events, including learning to evaluate adverse events using various analytical tools and data sources.
Contribute to activities related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from regulatory agencies.
The fellow may work in a combination of therapeutic areas including oncology, virology, or inflammatory diseases.
Exposure to other areas of safety including safety operations, analytics, and coding may be offered if interested
Safety in Clinical Trials:
Support the review of clinical trial protocols, Investigator’s Brochures, and clinical study reports.
Contribute to the preparation of informed consent forms.
Support the review and monitoring of clinical trial safety data.
Collaborate with Patient Safety Operations colleagues to ensure safety reporting issues are addressed.
The fellow will have an opportunity to collaborate with colleagues from other departments such as Regulatory Affairs, Clinical Development, Medical Affairs, Clinical Pharmacology, and Nonclinical Safety & Pathobiology to learn about how these functions interact with PS.
USC Graduate Coursework:
Complete required graduate coursework at USC with the opportunity to complete a Graduate Certificate Program in a variety of fields.
Leadership and Career Development:
Participate in the USC Mann School Professional Development and Leadership Retreat.
Minimum Application Requirements: The candidate must have completed a PharmD, MD, Ph.D., or equivalent doctorate from an accredited college or university within five years of initial appointment and a minimum doctoral program GPA of 3.0.
Interview Requests: Interviews are limited and will be scheduled on a rolling basis. Please submit your application, including your CV and a letter of intent, by November 30 to ASHP PPS and at the following link: https://usc.qualtrics.com/jfe/form/SV_djp6YFVrsUaHyFo
Please follow the document conventions listed below:
Document type: PDF
Document name: Last NameFirst Name_CV.pdf
Letter of Intent
Document type: PDF
Document name: Last NameFirst Name_LOI_PS.pdf
The letter of intent should describe your experience and interest inpatient safety and pharmacovigilance, how this fellowship will help you advance your career in the pharmaceutical industry, and what qualities/skills you have that would be useful to work in Patient Safety.
Please address letters to:
Susan Eng, PharmD Executive Director, Patient Safety
If you have any additional questions, please contact Susan Eng, PharmD, Executive Director, Patient Safety, at Susan.Eng2@gilead.com
The University of Southern California is one of the world’s leading private research universities. An anchor institution in Los Angeles, a global center for arts, technology and international trade, USC enrolls more international students than any other U.S. university and offers extensive opportunities for internships and study abroad. With a strong tradition of integrating liberal and professional education, USC fosters a vibrant culture of public service and encourages students to cross academic as well as geographic boundaries in their pursuit of knowledge.