Intern – Patient Safety, Oncology
Gilead SciencesAbout the role
For Current Gilead Employees and Contractors:
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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company’s mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs.
Position Overview:
You will learn about core Patient Safety Oncology pharmacovigilance activities, including signal detection, benefit-risk evaluation, risk management plans and risk minimization activities, aggregate safety reports, the role of PS Oncology in study-related activities including study-related documents and regulatory submissions. The intern will work under the close supervision of an experienced Global Therapeutic Area (TA) Safety Scientist or Physician.
Key Responsibilities will include, but are not limited to the following:
- Supports authoring or otherwise contributes to the preparation of aggregate safety reports and risk management plans (RMPs).
- Conducts signal detection and evaluation activities for assigned products in collaboration with the Global TA Safety Physician and Scientist as part of the continuous benefit-risk evaluation throughout the product lifecycle.
- Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
- May contribute to MSS activities and input related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
- May perform safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Showcase your work with a final poster board presentation near the conclusion of your internship
- Showcase your work with a final presentation (PPT) near the conclusion of your internship
Required Qualifications:
- Must be at least 18 years old
- Must have a minimum GPA of 2.8
- Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.
- Must be currently enrolled as a full-time student in a Bachelor’s/Masters/MBA/PhD program at an accredited US based university or college
- Must be a Rising Sophomore, Junior, or
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