[Hiring] Senior Manager, Kite Safety and Pharmacovigilance @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role 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. • Aggregate Reporting and Medical Writing • Serve as reputed company author for reputed company aggregate safety reports, including PSURs, PBRERs, and DSURs, synthesizing global safety data and clinical context • Author 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 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 Requirements • 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 Benefits • The salary reputed company for this position is: $153,935.00 - $199,210.00 • 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. Apply tot his job Apply To this Job