Intern - Medical Safety Science - Risk Mgmt

Location
Foster City, CA, United States
Posted
Dec 15, 2020
Ref
2100402
Required Education
Bachelors Degree
Position Type
Full time
Intern - Medical Safety Science - Risk Mgmt
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


We are the Medical Safety Science (MSS) group within the Global Patient Safety (GLPS) department. The MSS Group performs continuous and proactive medical surveillance and risk evaluation for all of Gilead's therapies throughout their life-cycle. MSS supports GLPS' mission to protect patients through timely collection and reporting of safety information and proactive and comprehensive risk/benefit evaluation, ensuring patient safety and Gilead's compliance with global regulations for all products and therapies throughout their life cycle by:
Proactively managing the safety profile of Gilead's investigational and marketed products. This responsibility involves systematic signal detection and critical review of aggregate safety data and literature for identification of potential safety concerns/signals.
Authorship of signal validation and assessment documents.
Authorship of global aggregate safety reports (e.g., PSUR/PBRERs), risk management plans, and responses to international regulatory agency safety enquiries.
Contributing to safety analyses in Regulatory submissions (e.g., Marketing Authorisation Application (MAAs), New Drug Application (NDAs)).
Performing safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies.
Creating and maintaining the company's procedural documents and templates in collaboration with internal and external functions.
The Position
The position exposes interns to the various components of MSS's functions by involvement in related tasks in drug safety monitoring in clinical trials and postmarket product use. Interns will contribute to projects, attend departmental team meetings, and work closely with professionals from a multitude of backgrounds, including PhDs, MDs, or PharmDs, in varied specialties, such as Oncology/Hematology, Virology, and Inflammation, or business document experts.
The internship is an entry-level position, beginning with an initial period of training under direct supervision. The responsibilities may include:
Supporting the Risk Management (RM) team in the identification and assessment of safety signals and authoring or contributing to sections of signal validation/assessment documents
Supporting quality control and, where required, authorship of assigned portions of aggregate reports
Collaborating with Gilead subject matter experts to contribute to the review and creation of risk language for non-Gilead investigational medicinal products
Participating in both internal and external educational initiatives and activities
Supporting the RM and RM-Connect team with ad hoc safety projects
Ideal Candidate
This opportunity is ideal for candidates looking to gain relevant corporate experience within the field of biopharmaceuticals. With ample opportunity for visibility and independence, the position will be a rare experience in preparation for a future career in a health-related field.
The ideal candidate demonstrates:
A strong desire to pursue a career within a health-related field and is prepared to display autonomy through various independent projects and assignments
Demonstrates excellent attention to detail, teamwork and initiative, and professionalism in a fast-paced corporate environment
Excellent verbal and written communication skills
Proficiency in Microsoft Excel, Word, Outlook and Power Point
A strong academic record and evidence of relevant extracurricular experiences
Requirements
Enrolled in a 4-year accredited University/College, seeking a degree in science or other health related fields
Available to complete the internship for 10-12 consecutive weeks between the months of
May and September
Maintain confidentiality and adhere to all company policies and regulations

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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 careers@gilead.com for assistance.

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