Senior Manager, Drug Safety & Pharmacovigilance

About the role

This role will oversee core pharmacovigilance operations, with a strong emphasis on safety surveillance, case processing oversight, and medical review quality. The position partners closely with vendors and internal stakeholders to ensure global compliance, timely reporting, and strong execution across safety activities. It will also contribute to the development of safety-related plans and SOPs while helping strengthen the organization’s overall pharmacovigilance framework.

Responsibilities

• Manage daily pharmacovigilance operations and vendor oversight
• Monitor compliance with global regulatory requirements and reporting timelines
• Perform quality reviews of safety documentation to ensure regulatory compliance
• Support safety data reconciliations and vendor performance monitoring
• Contribute to the development of safety-related plans and SOPs

Qualifications

• Bachelor’s degree in life sciences or related field required; healthcare professional degree preferred
• 6+ years of experience in Drug Safety/Pharmacovigilance in pharmaceutical, biotechnology, or CRO settings
• Strong experience with ICSR processing and medical review, including regulatory compliance
• Experience with safety surveillance and signal detection activities
• Knowledge of FDA regulations, ICH guidelines, and EU pharmacovigilance requirements

Benefits

• Premium health, financial, work-life, and well-being offerings for employees and dependents
• Wellness and employee support programs
• Life insurance and disability coverage
• Retirement plans with employer match
• Generous paid time off

Compensation

$132,000 – $172,000 annually

Location

Remote — US-based candidates only; no visa sponsorship available