United Spinal Association Jobs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) 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

Oversight of Individual Case Safety Reports (ICSRs) processing performed by vendor(s)

• Responsible for task management of junior employees performing operational job responsibilities that ensure compliance of pharmacovigilance activities including the collection, review, evaluation, processing, and submission of adverse event (AE) information received by Gilead PS Responsible for internal and cross functional team representation and will lead cross functional work streams as required

• Addresses identified issues escalated to management and coordinates for resolution

• Oversees training of junior staff

• Leads or actively participates in functional projects

• May be responsible for performance management

Job Responsibilities:

• Review of ICSR compliance, identifying reasons for late cases and implementing corrective and preventative actions

• Manages routine and non-routine daily case management activities

• • Ensures team compliance with internal processes to meet all applicable internal/external reporting requirements for ICSR

• • Addresses/resolves issues/concerns in a timely manner.

• • Oversee all activities or responsibilities that are delegated to junior staff members and ensure quality and accuracy of deliverables

• • Oversees training and/or on-boarding activities

• • Leads and manages functional projects and work streams, taking responsibility for specific projects, with minimal direction from senior management

• • Leads cross-functional projects and serve as a point of contact to other functions in the organization and outside the organization.

• • Develops a process for quality review of data for the applicable functional area

• • Understands and manages the execution of PS Business Continuity processes, as applicable

• • May be responsible for supervision and performance review

Knowledge & Skills:

• Excellent interpersonal and communication skills, both written and oral

• 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

• The ability to provide direction to a team and to influence peers and team members appropriately

• Ability to provide constructive feedback in a timely manner high-energy and fast paced environment

Education & Experience:

Exempt Professional Leveling Guide:

7+ Years with BA/ BS

5+ Years with MA/ MS

This role will be based in our Cambridge office and hybrid 3 days per week / 2 days work from home

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.