Register for the 2023 Personnel Placement Service (PPS) to request an interview.

Details

Posted: 10-Oct-23

Location: Foster City, California

Type: Fellowship

Categories:

Pharmacy

Preferred Education:

PharmD

Dear Prospective Fellowship Candidate, 

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: 

Pharmacovigilance: 

• 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.

Cross-Functional Collaboration: 

• 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: 

CV

• 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 in patient 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

Or

Olivia Fu, MD, Executive Director, Patient Safety, at Olivia.Fu@gilead.com.

If you are interested in learning more, we welcome you to join our online webinar: 

USC-Gilead Sciences Fellowship Webinar 

• Link to sign up for the webinar: USC-Gilead Fellowship Info Session Webinar Registration
  • Date: November 6, 2023, at 4:30 to 6:00 PM PST (7:30 to 9:00 PM EST)
  • After you complete the webinar registration form, the Zoom link will be sent out a few days prior to the webinar

Additional information about the application process, brochures, and other information are available at: https://mann.usc.edu/program/fellowship-programs/

We look forward to meeting you! 

Best Regards, 
William C. Gong, PharmD 
Director, Fellowship Programs 
wgong@usc.edu 

About USC

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.

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