Senior Manager, Kite Safety, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific and strategic oversight for pharmacovigilance initiatives related to Kite’s investigational and marketed products

• Act as a senior expert in pharmacovigilance science

• Direct intricate safety analyses, regulatory deliverables, and the execution of cross-functional safety strategies

• Take the lead in authoring complex aggregate safety reports, including PSURs, PBRERs, and DSURs

• Integrate global safety data with clinical context

• Draft and evaluate safety documents that support regulatory submissions and lifecycle management

• Oversee safety reviews, encompassing search strategy design, data evaluation methods, and scientific interpretation of safety data

• Analyze individual case safety reports to identify and evaluate potential safety signals

• Assist in signal detection and management efforts

• Prepare and lead responses to safety-related inquiries from global health authorities

• Support product labeling initiatives, including CCDS, USPI, SmPC, and Investigator’s Brochure

• Act as the Pharmacovigilance Science Safety Lead for products under development

• Collaborate 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 adherence to global regulations and internal procedures

• Assist with audits and inspections, contributing to activities that ensure inspection readiness

⛳️ 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

• Minimum of 5 years of direct pharmacovigilance experience in aggregate reporting, safety analysis, and regulatory support activities

• Solid understanding of FDA, EMA, and ICH safety reporting regulations and GVP guidelines

• Experience utilizing safety databases and tools, such as Argus, Rave, MedDRA, and WHO Drug

• Capability to independently lead complex safety deliverables and make informed scientific decisions

• Exceptional written and verbal communication skills

• Proficient medical writing skills

• Ability to work collaboratively across functions and cultures, leading within matrixed project teams

🏝️ Benefits

• Discretionary annual bonus eligibility

• Discretionary stock-based long-term incentives eligibility may vary based on role

• Paid time off

• Company-sponsored medical insurance

• Company-sponsored dental insurance

• Company-sponsored vision insurance

• Company-sponsored life insurance