Senior Manager, Kite Safety, Pharmacovigilance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $153.9k - $219.1k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Provide scientific and strategic leadership for pharmacovigilance activities supporting Kite’s investigational and marketed products • Serve as a senior pharmacovigilance science expert • Lead complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution • Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs • Synthesize global safety data and clinical context • Author and review safety documents supporting regulatory submissions and lifecycle management • Lead safety reviews, including search strategy design, data evaluation methodologies, and scientific interpretation of safety data • Review individual case safety reports to identify and assess potential safety signals • Support signal detection and management activities • Prepare and lead responses to safety-related requests from global health authorities • Support product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure • Serve as Pharmacovigilance Science Safety Lead for products in development • Partner with Clinical, Regulatory, Medical Affairs, and other stakeholders • Provide 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

🎯 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 • Ability to independently lead complex safety deliverables and make sound scientific judgments • Excellent written and verbal communication skills • Strong medical writing capability • Ability to collaborate across functions and cultures and lead within matrixed project teams

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility may vary based on role • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance