Senior Manager, Kite Safety and Pharmacovigilance
Ladders · United States · 1 wk ago
RemoteRemoteManagement$154k–$219k/yrFull-time
For our client, a leader in the Pharmaceuticals & Biotech space, we are seeking a Senior Manager of Kite Safety and Pharmacovigilance. This role will turn data into practical insight that improves visibility, decision-making, and business performance. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. The position offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.
Responsibilities
- Lead author for complex aggregate safety reports such as PSURs and DSURs
- Author and review critical safety documents for regulatory submissions
- Design safety reviews and evaluate methodologies for data interpretation
- Identify safety signals through review of individual case reports
- Prepare responses for safety-related inquiries from global health authorities
- Partner with cross-functional teams for product safety strategy execution
- Ensure compliance with global regulations and support audits
Requirements
- MD with 0+ years or doctorate with 2+ years of relevant experience
- Master's degree with 6+ years or bachelor's with 8+ years of relevant experience
- 5+ years of direct pharmacovigilance experience in aggregate reporting and safety analysis
- Strong knowledge of FDA, EMA, and ICH safety regulations
- Proficient with safety databases like Argus, Rave, and MedDRA
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans
- Paid time off
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility
Pay
$153,935 – $219,120 annually
Location: Remote - US based candidates only, no visa sponsorship available