Job DescriptionThe
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.
Key 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
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
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
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 include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
