Director/Senior Director, Pharmacovigilance Operations

Responsibilities

• Build and execute the company's pharmacovigilance and drug safety capabilities
• Ensure an effective, scalable, and inspection-ready pharmacovigilance system for late-stage clinical development and commercial launch
• Lead safety operations, benefit-risk management, signal detection, and aggregate reporting
• Manage safety governance, vendor oversight, and global regulatory compliance
• Establish the people, processes, systems, and external partnerships required for commercial pharmacovigilance

Requirements

• Strong scientific and medical judgment
• Practical operational experience implementing pharmacovigilance capabilities in a growing organization
• Experience supporting regulatory submissions and post-marketing safety surveillance

About the Company

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders, specifically targeting hypoglycemia due to congenital and acquired forms of hyperinsulinism.