Director / Senior Director, Pharmacovigilance Operations
rezolutebio · Remote
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 at rezolutebio.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:
- 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.
- 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.
- 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.
- 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 databases, medical information, quality/product complaints, partners, patient support programs, and other relevant systems.
- Partner closely with Quality Assurance to establish and maintain the company's pharmacovigilance quality system.
- Develop, implement, and maintain PV policies, SOPs, work instructions, and controlled processes.
- Establish appropriate deviation, CAPA, quality-event, and compliance-monitoring processes related to pharmacovigilance.
- Maintain continuous PV inspection readiness and participate in regulatory authority inspections, partner audits, vendor audits, and internal audits.
- Ensure documentation demonstrates effective oversight of outsourced PV activities.
- Support development and maintenance of applicable PV system documentation and regulatory requirements, including the Pharmacovigilance System Master File (PSMF) where required.
- Develop and maintain Safety Data Exchange Agreements (SDEAs) and pharmacovigilance provisions within licensing, distribution, co-development, and commercialization agreements.
- Establish clear responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance.
- Represent the company on joint safety committees and other alliance governance forums.
- Monitor partner compliance with contractual PV obligations and implement corrective actions as necessary.
- Maintain current knowledge of applicable global pharmacovigilance regulations and guidance, including requirements of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), ICH, and other relevant health authorities.
- Ensure company PV processes remain compliant as products transition from investigational to marketed status and expand geographically.
- Support preparation for health authority meetings and responses to regulatory questions regarding product safety and benefit-risk.
Qualifications:
- Advanced degree in a health or life sciences discipline strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training.
- Candidates with a master's or bachelor's degree and significant relevant pharmacovigila