Senior Manager, Kite Safety and Pharmacovigilance

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

The Senior Manager Kite Safety and Pharmacovigilance provides scientific and strategic leadership for pharmacovigilance activities supporting Kites 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 Investigators 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

Masters degree with 6 years of relevant experience

OR

Bachelors 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

The salary range for this position is:

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:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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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 (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Please apply via the Internal Career Opportunities portal in Workday.