Senior Manager, Kite Safety and Pharmacovigilance

Senior Manager, Kite Safety and Pharmacovigilance

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.

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

People Leader Accountabilities:

• 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.

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.

• 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. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

• Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

• For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

• NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

• YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

• Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer.

• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

• Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

• Please apply via the Internal Career Opportunities portal in Workday.

Share:

• Job Requisition IDR0054369

• Full Time/Part TimeFull-Time

• Job LevelManager

• Remote TypeOnsite - Hybrid Eligible

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