Senior Safety Specialist

5 months ago

Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

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:

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