Senior Manager, Kite Safety, Pharmacovigilance
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Job Description
Senior pharmacovigilance leader supporting Kite’s CAR T-cell cancer immunotherapies. Leading safety analyses, aggregate reports, regulatory submissions, and cross-functional safety strategy.
Responsibilities:
- Provide scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products
- Serve as a senior pharmacovigilance science expert
- Lead complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution
- Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs
- Synthesize global safety data and clinical context
- Author and review safety documents supporting regulatory submissions and lifecycle management
- Lead safety reviews, including search strategy design, data evaluation methodologies, and scientific interpretation of safety data
- Review individual case safety reports to identify and assess potential safety signals
- Support signal detection and management activities
- Prepare and lead responses to safety-related requests from global health authorities
- Support product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure
- Serve as Pharmacovigilance Science Safety Lead for products in development
- Partner with Clinical, Regulatory, Medical Affairs, and other stakeholders
- Provide safety content for clinical protocols, clinical study reports, informed consent forms, and other development and post-marketing documents
- Ensure compliance with global regulations and internal procedures
- Support audits and inspections and contribute to inspection readiness activities
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
- Ability to independently lead complex safety deliverables and make sound scientific judgments
- Excellent written and verbal communication skills
- Strong medical writing capability
- Ability to collaborate across functions and cultures and lead within matrixed project teams
Benefits:
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility may vary based on role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
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