Senior Safety Specialist

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