Gilead Sciences

Creating Possible

Senior Manager, Kite Safety and Pharmacovigilance

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1987H1B SponsorCompany Site LinkedIn

Location

United States

Posted

14 days ago

Salary

$153.9K - $199.2K / year

Seniority

Senior

Experience acceptedEnglish

Job Description

• Provide scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products • Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs • Author and review high-impact safety documents supporting regulatory submissions and lifecycle 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 • Prepare and lead responses to safety-related requests from global health authorities • Serve as Pharmacovigilance Science Safety Lead for products in development • Ensure compliance with global regulations and internal procedures

Job 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 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