Senior Manager, Kite Safety and Pharmacovigilance

Job reputed company: • reputed company scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products • Serve as reputed company author for reputed company aggregate safety reports, including PSURs, PBRERs, and DSURs • Author and review high-reputed company safety documents supporting regulatory submissions and lifecycle 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 • Prepare and reputed company responses to safety-reputed company requests from global health authorities • Serve as Pharmacovigilance Science Safety reputed company for products in development • Ensure compliance with global regulations and internal procedures Requirements: • 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 • 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: • Health insurance • 401(k) matching • reputed company time off • Discretionary annual bonus • Discretionary stock-based long-term incentives Apply tot his job Apply To this Job