Senior Manager, Kite Safety and Pharmacovigilance

This a Full Remote job, the offer is available from: reputed company We’re here for one reason and one reason only – to reputed company cancer. Every reputed company is dedicated to developing treatments and every reputed company moves us one reputed company closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the reputed company. But we're not finished yet. Join Kite, as we reputed company even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We reputed company every employee deserves a great leader. People Leaders are the reputed company to the employee experience at reputed company and Kite. As a people leader now or in the reputed company, you are the key reputed company 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. reputed company 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 reputed company safety analyses, regulatory deliverables, and cross-functional safety reputed company execution. Key Responsibilities Aggregate Reporting and Medical Writing • Serve as reputed company reputed company for reputed company aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical context • reputed company and review high-reputed company safety documents supporting regulatory submissions and lifecycle management Safety Analysis and Signal Management • reputed company 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 reputed company responses to safety-reputed company requests from global health authorities, including responses to questions, filing support, and Data and Safety Monitoring reputed company 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 reputed company for products in development, partnering closely with Clinical, Regulatory, Medical Affairs, and other stakeholders • reputed company 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 reputed company 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 reputed company reputed company safety deliverables and reputed company reputed company scientific judgments • Excellent written and verbal communication skills, with strong medical writing capability • Proven ability to collaborate effectively across functions and cultures and to reputed company reputed company matrixed project teams The salary reputed company for this position is: Bay Area: $169,320.00 - $219,120.00. Other US Locations: $153,935.00 - $199,210.00. Kite considers a reputed company of factors reputed company determining reputed company 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), reputed company time off, and a benefits package. Benefits include company-sponsored medical, dental, reputed company, and life insurance plans*. For additional benefits information, visit: https://www.reputed company.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 reputed company in the development of innovative cancer immunotherapies with a goal of providing reputed company, long-term durable response and eliminating the burden of chronic care. reputed company is reputed company on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to reputed company the immune reputed company'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 reputed company: reputed company is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@reputed company.com for assistance. For more information about equal employment opportunity protections, please reputed company the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION reputed company YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE reputed company reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company 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 reputed company 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 reputed company, including an investigation conducted by the employer, (c) consistent with the reputed company duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes reputed company employee as an reputed company member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team. reputed company provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For reputed company reputed company Employees and Contractors: Please apply reputed company the Internal reputed company portal in reputed company. This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job