Senior Manager, Kite Safety and Pharmacovigilance
Job Description:
• 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
Apply Now
Apply Now
• 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
Apply Now
Apply Now