Register for the 2024 Personnel Placement Service (PPS) to request an interview.

Details

Posted: 10-Oct-24

Location: Foster City, California

Type: Fellowship

Categories:

Pharmacy

Job Setting:

Pharmaceutical Science/Industry

This is NOT the formal application. Please apply through the USC application portal found on this page to be considered for this position: https://mann.usc.edu/program/fellowship-programs/admissions/

Applications submitted through PPS will only be used to contact final-round candidates for interviews at ASHP Midyear Meeting.

Dear Prospective Fellowship Candidate,

The USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences and Gilead Sciences, Inc. are proud to offer a 2-year Fellowship in Patient Safety (PS) for two doctoral candidates or graduates (PharmD, MD, PhD, or equivalent doctorate degree). Patient Safety is a crucial part of drug development and commercialization to predict, mitigate, manage, and communicate the risks of Gilead's medicines so patients can derive the maximum benefit. The fellow will be an integral part of the team and will work closely with our PS Scientists, Physicians, and Global Safety Leads on site at Gilead Headquarters located in Foster City, California. Of note, this role may involve occasional travel for industry conferences and meetings to enhance the fellows’ professional network and experience.

Duration: 2 years (July 1, 2025 – June 30, 2027)

Positions Available: 2

Location: Foster City, California

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
  • Preparation of aggregate safety reports such as Development Safety Update Reports (DSUR) and PBRER (Periodic Benefit Risk Evaluation Report)
  • Development and maintenance of Risk Management Plans (RMPs)
  • Evaluation of Individual Case Safety Reports (ICSRs)
• 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 the evaluation of adverse events while utilizing 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.
• Work in a combination of therapeutic areas including oncology, virology, or inflammatory diseases.
• Explore diverse safety domains including safety operations, analytics, and coding based on availability and interest.
  
  

Safety in Clinical Trials:

• Support the review of clinical trial protocols, clinical trial safety data, Investigator’s Brochures, and clinical study reports.
• Contribute to the preparation of informed consent forms.
• Collaborate with Patient Safety Operations colleagues to ensure safety reporting issues are addressed.

Cross-Functional Collaboration:

• Collaborate with colleagues from other departments including 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 the University of Southern California with the opportunity to complete a Graduate Certificate Program in a variety of fields.

Leadership and Career Development:

• Participate in the Fellowship Programs’ Professional Development and Leadership Retreat.

Minimum Application Requirements:

The candidate must be a US citizen/permanent resident and have completed a PharmD, MD, PhD, or equivalent doctorate degree from an accredited college or university within five years of initial appointment and a minimum doctoral program GPA of 3.0, have good oral and written communication skills, ethics, professionalism, leadership, and an interest in the biopharmaceutical industry. 

Interview Requests: Interviews are limited and will be scheduled on a rolling basis. For early consideration, please submit your application, including your CV and a letter of intent, by November 30, 2024 and at the following link: https://provost.sma.usc.edu/prog/usc_alfred_e_mann_school_of_pharmacy_and_pharmaceutical_sciences_fellowship/   

Final interviews may be conducted virtually, at the ASHP Midyear Clinical Meeting, or on-site at Gilead headquarters located in Foster City, CA.

For all applications:

• When submitting documents, please submit as a PDF file using the following naming conventions:
  • Last name_First name_CV_Position Name.pdf
  • Last name_First name_LOI_Position Name.pdf

The letter of intent (LOI) should highlight your background and passion for patient safety, how this fellowship aligns with your career goals in the pharmaceutical industry, and the unique qualities or skills you would bring to our Patient Safety Team. Please address your LOI to:

Susan Eng, PharmD
Executive Director, Patient Safety (Susan.Eng2@gilead.com)

and

Olivia Fu, MD

Executive Director, Patient Safety (Olivia.Fu@gilead.com)

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.

Connections working at USC