Director / Senior Director, Pharmacovigilance Operations

About this role

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders

More information can be found atrezolutebio.com

The Director / Senior Director, PharmacovigilanceOperations will play a critical leadership role in building and executing the company’s pharmacovigilance and drug safety capabilities as the organization advances its lead product toward regulatory approval and commercial launch.

This individual will be responsible for ensuring an effective, scalable, and inspection-ready pharmacovigilance system supporting late-stage clinical development, regulatory submissions, product launch, and post-marketing safety surveillance. The role will provide leadership across safety operations, benefit-risk management, signal detection and management, aggregate reporting, safety governance, vendor oversight, and global regulatory compliance.

As the company evolves from a development-stage organization to a commercial biopharmaceutical company, the Director/Senior Director will help establish the people, processes, systems, governance, and external partnerships required for commercial pharmacovigilance.

The successful candidate will combine strong scientific and medical judgment with practical operational experience implementing pharmacovigilance capabilities in a growing organization.

Key Responsibilities

Pharmacovigilance Strategy & Leadership

• Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance.

• Establish a scalable PV operating model appropriate for the company's anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure.

• Serve as a senior safety leader and subject matter expert for pharmacovigilance matters across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and other functions.

• Provide safety input into clinical development plans, regulatory submissions, labeling strategies, launch-readiness activities, medical information processes, and lifecycle management.

• Represent Pharmacovigilance on cross-functional governance and product development teams.

• For the Senior Director level, provide strategic leadership to executive management regarding emerging safety issues, benefit-risk considerations, regulatory risk, and organizational PV capabilities.

Commercial Launch Readiness

• Lead PV readiness activities required to transition from a clinical-stage to commercial-stage pharmacovigilance organization.

• Develop and maintain a comprehensive PV launch-readiness plan, including commercial adverse event intake, case processing, reconciliation, vendor interfaces, escalation pathways, reporting responsibilities, and business continuity.

• Establish processes for adverse event and product complaint intake from Medical Affairs, Medical Information, Commercial, Market Access, patient support programs, digital channels, distributors, partners, and other potential sources.

• Partner with Quality and Commercial functions to ensure appropriate identification, triage, reconciliation, and escalation of safety information associated with product complaints.

• Establish PV requirements and training for employees, contractors, vendors, field-based personnel, and other groups who may receive adverse event information.

• Ensure PV systems, procedures, resources, vendors, and governance structures are operational and inspection-ready prior to product launch.

Safety Surveillance & Benefit-Risk Management

• Establish and oversee processes for signal detection, validation, prioritization, assessment, management, and documentation.

• Lead cross-functional safety review or Safety Management Team meetings.

• Provide strategic oversight of aggregate safety reports and periodic benefit-risk assessments, including applicable DSURs, PBRERs/PSURs, and other periodic reports.

• Lead or contribute to Risk Management Plans and other risk minimization activities.

• Partner with Regulatory Affairs and Clinical Development on safety-related labeling changes, investigator communications, regulatory responses, and health authority interactions.

Pharmacovigilance Operations

• Provide strategic and operational oversight of adverse event case management across clinical and post-marketing sources.

• Ensure appropriate collection, assessment, processing, follow-up, quality review, and submission of ICSRs within applicable regulatory timelines.

• Oversee PV vendors, including safety database providers, case-processing vendors, medical review resources, literature surveillance providers, and aggregate reporting partners.

• Establish meaningful operational metrics, quality indicators, and vendor performance measures to monitor the effectiveness of the PV system.

• Develop internal capabilities versus outsourced capabilities based on company growth, volume, geographic footprint, and portfolio requirements.

• Ensure effective reconciliation of safety information across clinical…