Senior Manager, Kite Safety and Pharmacovigilance
Gilead Sciences
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $153,935 - $199,210 per year
Job Level
About the role
- Provide scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products
- Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs
- Author and review high-impact safety documents supporting regulatory submissions and lifecycle management
- Lead safety reviews, including design of search strategies, data evaluation methodologies, and scientific interpretation of individual and aggregate safety data
- Review individual case safety reports to identify and assess potential safety signals
- Prepare and lead responses to safety-related requests from global health authorities
- Serve as Pharmacovigilance Science Safety Lead for products in development
- Ensure compliance with global regulations and internal procedures
Requirements
- MD with 0+ years of relevant experience OR Doctorate with 2+ years of relevant experience OR Master’s degree with 6+ years of relevant experience OR Bachelor’s degree with 8+ years of relevant experience
- 5+ years of direct pharmacovigilance experience performing aggregate reporting, safety analysis, and regulatory support activities
- Strong knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
- Experience working with safety databases and tools, including Argus, Rave, MedDRA, and WHO Drug
- Demonstrated ability to independently lead complex safety deliverables and make sound scientific judgments
- Excellent written and verbal communication skills, with strong medical writing capability
- Proven ability to collaborate effectively across functions and cultures and to lead within matrixed project teams
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceaggregate reportingsafety analysisregulatory supportsafety signal identificationdata evaluation methodologiesscientific interpretationmedical writing
Soft Skills
leadershipcommunicationcollaborationscientific judgment
Certifications
MDDoctorateMaster’s degreeBachelor’s degree