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Responsibilities
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.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 ResponsibilitiesAggregate Reporting and Medical WritingServe as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical contextAuthor and review high-impact safety documents supporting regulatory submissions and lifecycle managementSafety Analysis and Signal ManagementLead safety reviews, including design of search strategies, data evaluation methodologies, and scientific interpretation of individual and aggregate safety dataReview individual case safety reports to identify and assess potential safety signals and support signal detection and management activities in accordance with procedural documentsRegulatory and Health Authority EngagementPrepare and lead responses to safety-related requests from global health authorities, including responses to questions, filing support, and Data and Safety Monitoring Board requestsSupport development and maintenance of product labeling, including CCDS, USPI, SmPC, and Investigator’s BrochureCross-Functional Leadership and ComplianceServe as Pharmacovigilance Science Safety Lead for products in development, partnering closely with Clinical, Regulatory, Medical Affairs, and other stakeholdersProvide safety content for clinical protocols, clinical study reports, informed consent forms, and other development and post-marketing documentsEnsure compliance with global regulations and internal procedures; support audits and inspections and contribute to inspection readiness activitiesBasic Qualifications:MD with 0+ years of relevant experienceORDoctorate with 2+ years of relevant experienceORMaster’s degree with 6+ years of relevant experienceORBachelor’s degree with 8+ years of relevant experiencePreferred Qualifications, Experience, and Skills:5+ years of direct pharmacovigilance experience performing aggregate reporting, safety analysis, and regulatory support activitiesStrong knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelinesExperience working with safety databases and tools, including Argus, Rave, MedDRA, and WHO DrugDemonstrated ability to independently lead complex safety deliverables and make sound scientific judgmentsExcellent written and verbal communication skills, with strong medical writing capabilityProven ability to collaborate effectively across functions and cultures and to lead within matrixed project teamsThe 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*.About UsChange The World With UsEveryone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
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