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Senior Manager, Kite Safety, Pharmacovigilance
Gilead Sciences. Provide scientific and strategic leadership for pharmacovigilance activities supporting investigational and marketed products .
Posted 9/25/2026full-timeFoster City • California • United StatesSenior💰 $169,320 - $219,120 per yearWebsite
About the role
Key responsibilities & impact- Provide scientific and strategic leadership for pharmacovigilance activities supporting investigational and marketed products
- 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
- 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
- Create inclusion, develop talent, and empower teams as a people leader
Requirements
What you’ll need- 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 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, with strong medical writing capability
- Ability to collaborate across functions and cultures and lead within matrixed project teams
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Equal employment opportunity protections
- Reasonable accommodation during the job application process