Intern - GLPS Standards & Collaboration
Intern - GLPS Standards & Collaboration
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Pharmacovigilance (PV) is defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem" (WHO). Randomized controlled clinical trials provide a lot of information on safety in selected treated populations under conditions governed by study protocols. However, this information is limited. Further data from post-marketing studies are needed to inform on safety in population intended to be treated under real-life conditions. Therefore, the importance of post marketing pharmacovigilance cannot be overstated.
The main PV activities of GLPS are centered at three sites: Foster City and Santa Monica in California, USA and Cambridge in the UK. GLPS is organized within four distinct areas:
- GLPS Operations and Systems: Responsible for processing Individual Case Safety Reports (ICSRs) e.g. adverse events, pregnancy reports, medication errors from receipt through to submission to external parties and operational support of clinical studies. Maintenance of the global Oracle safety database and extraction of data.
- Medical Safety Science: Covers the medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection.
- European (EU) Qualified Person for Pharmacovigilance (QPPV) Office: Overview of the PV system in the EU
- Standards and Collaborations (S&C): Responsible for review of PV-related policies and global regulations, PV Alliance management and PV Agreements, Solicited Programs and Risk Evaluation & Mitigation Strategies (REMS), audit and inspection readiness/support, training, performance and quality measures, PV support for Affiliates and Distributors
The GLPS department at Gilead works across the Gilead product portfolio, supporting the research and development activities, clinical trials and post marketing activities for all the Gilead therapy areas. The GLPS department supports PV activities all countries by collaborating with affiliate offices and distributors. GLPS work extensively and collaboratively with other disciplines including clinical research, clinical operations, regulatory affairs, medical affairs and other groups essential for the development, approval and marketing of pharmaceutical products.
This role will include a broad exposure to PV and the various components of GLPS Standards and Collaborations (S&C) and potential involvement in related tasks across multiple functions within S&C as described above. Interns will have the opportunity to contribute to projects, attend departmental team meetings, and work closely with professionals from a multitude of backgrounds. The ideal candidate is looking for an opportunity to gain relevant corporate experience within the pharmaceutical/ biotech arena. With the unique opportunity for visibility, the position will be a rare experience in preparation for a future career in a health related field.
The internship is an entry-level position, beginning with an initial period of training under direct supervision. The exact role will be determined by the business need at the time of entry but may include:
- Supporting S&C team(s) by participating in one or more of the following activities depending on the intern's interest/competency: solicited program tracker update/Pharmacovigilance System Master File (PSMF) support, reconciliation activities, vendor training support, update of training materials, REMS document management, review of PV related regulations, procedural document management support, and supporting performance/quality metrics related activities.
- Participating in both internal and external educational initiatives and activities
- Contributing toward completion organizational projects and goals
- Attending and participating in interdepartmental team meetings
- Assist with various project within S&C team including process enhancement efforts
- Indicates a strong desire to establish a career within a health related field and is prepared to display autonomy through various projects and assignments
- Demonstrates excellent attention to detail, teamwork and initiative, is able to demonstrate professionalism in a fast-paced corporate environment
- Exhibits proficiency in verbal and written communication, including but not limited to Microsoft Excel, Word, Outlook and Power Point
- Maintains a strong academic record with relevant extracurricular experiences
- Summer Intern at least 18 years old
- Enrolled in a 4-year accredited University/College; including enrollment in Fall Semester after internship
- Maintain confidentiality and adhere to all company policies and regulations
- Ability to complete 10-12 consecutive weeks between May and September
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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