Senior Manager, Kite Safety and Pharmacovigilance

Kite Pharma

4d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description 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 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

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

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level