Senior Safety Specialist

Gilead Sciences

Gilead Sciences

Operations
Cambridge, UK
Posted on Thursday, July 11, 2024

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

Title: Senior Safety Specialist


Job Overview/Summary:
• As part of a broader PS team, performs 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
• 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
  • • 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
  • JD – Patient Safety (PS), Strategic Operations
  • Oversight of Individual Case Safety Reports (ICSRs) processing performed by vendor(s)
  • Review of ICSR compliance, identifying reasons for late cases and documenting corrective and preventative actions


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


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 to apply for this job.