Senior Manager, Kite Safety and Pharmacovigilance

About the role

We’re here for one reason – to cure cancer. 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.

Responsibilities

• Aggregate Reporting and Medical Writing
  • 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
• Safety Analysis and Signal 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
• Regulatory and Health Authority Engagement
  • 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
• Cross-Functional Leadership and Compliance
  • 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

Qualifications

Basic Qualifications:

• 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

Skills

Preferred Qualifications, Experience, and Skills:

• 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

Pay

The salary range for this position is:

• Bay Area: $169,320.00 - $219,120.00
• Other US Locations: $153,935.00 - $199,210.00

Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit: Gilead Careers - Compensation, Benefits and Wellbeing.