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Senior Safety Specialist
3 months ago
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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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 part of a broader PS team, performs operational job responsibilities that ensure compliance of pharmacovigilance activities including supporting the PS Global Safety Lead or delegate in clinical trial protocol review, ensuring that the clinical database collects and reports essential data to the safety database, initiation of applicable Clinical Trial Safety Reporting Procedure document(s), submitting safety database study configurations, updating safety fields in the Clinical Trial Management System, reconciliation between clinical and safety databases, Trial Master File filing and Quality Checks, collaboration with Study Management Team, and audit/inspection support. Additionally includes the collection, review, evaluation, processing, and submission of adverse event (AE) information received by Gilead PS.
Actively participates in internal and cross functional teams as a representative of functional group; may lead functional work streams as required
Identifies issues and proactively proposes possible solutions to management
May assist management in obtaining resolution
Provides input into team trainings and may lead trainings
May lead functional projects
Job Responsibilities:
Performs routine and non-routine daily case management activities independently and provides direction as needed to junior staff assists junior staff as needed
Leads training and/or on-boarding activities (e.g. Safety Trainings for Study Kick Off Meetings)
Leads projects of high complexity
Participates in cross-functional projects may represent functional area at project meetings
May serve as a point of contact to other functions inside and outside of the organization
May develop and/or assist with quality review of data for the applicable functional area
Knowledge & Skills:
Excellent interpersonal and communication skills, both written and oral
Excellent computer skills (e.g. Microsoft Office, etc.)
A quality driven individual with strong attention to detail and accuracy is required
Strong organizational skills, and ability to adapt to change
Safety database and/or data entry experience required
Understanding of medical terminology and the ability to summarize medical information required
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations required
Ability to effectively represent PS Strategic Operations on multidisciplinary teams
Education & Experience:
Exempt Professional Leveling Guide:
6+ Years with BA/ BS
4+ Years with MA/ MS
The salary range for this position is: $124, $160, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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