Senior Manager, Kite Safety and Pharmacovigilance

Gilead Sciences•Foster City, CA

3d•$153,935 - $219,120

About The Position

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. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

Requirements

MD with 0+ years of relevant experience
Doctorate with 2+ years of relevant experience
Master’s degree with 6+ years of relevant experience
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

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
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
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
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
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.