Senior Manager, Kite Safety and Pharmacovigilance
Kite Pharma•US - CA - Bay Area - offsite, CA
•$153,935 - $219,120
About The Position
The Senior Manager, Kite Safety and Pharmacovigilance provides scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products. This role serves as a senior pharmacovigilance science expert, leading complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution.
Requirements
- MD with 0+ years of relevant experience
- Doctorate with 2+ years of relevant experience
- Master’s degree with 6+ years of relevant experience
- Bachelor’s degree with 8+ years of relevant experience
Nice To Haves
- 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
Responsibilities
- Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical context
- 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 and support signal detection and management activities in accordance with procedural documents
- Prepare and lead responses to safety-related requests from global health authorities, including responses to questions, filing support, and Data and Safety Monitoring Board requests
- Support development and maintenance of product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure
- Serve as Pharmacovigilance Science Safety Lead for products in development, partnering closely 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
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
