Rezolute, Inc.

Operations

• 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 for the anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure
• Serve as a senior safety leader and subject matter expert 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
• Lead PV readiness activities for transition from clinical-stage to commercial-stage pharmacovigilance
• Develop and maintain a comprehensive PV launch-readiness plan
• Establish processes for adverse event and product complaint intake, reconciliation, escalation, and reporting
• Establish PV requirements and training for employees, contractors, vendors, field-based personnel, and other groups receiving adverse event information
• Ensure PV systems, procedures, resources, vendors, and governance structures are operational and inspection-ready before product launch
• Establish and oversee signal detection, validation, prioritization, assessment, management, and documentation
• Lead cross-functional safety review or Safety Management Team meetings
• Oversee aggregate safety reports and periodic benefit-risk assessments, including DSURs, PBRERs/PSURs, and other periodic reports
• Lead or contribute to Risk Management Plans and risk minimization activities
• Partner with Regulatory Affairs and Clinical Development on 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 collection, assessment, processing, follow-up, quality review, and submission of ICSRs within regulatory timelines
• Oversee PV vendors, including safety database, case-processing, medical review, literature surveillance, and aggregate reporting providers
• Establish operational metrics, quality indicators, and vendor performance measures
• Develop internal versus outsourced capabilities based on company growth, volume, geographic footprint, and portfolio requirements
• Ensure reconciliation of safety information across clinical databases, medical information, quality/product complaints, partners, patient support programs, and other systems
• Partner with Quality Assurance to establish and maintain the pharmacovigilance quality system
• Develop, implement, and maintain PV policies, SOPs, work instructions, and controlled processes
• Establish deviation, CAPA, quality-event, and compliance-monitoring processes
• Maintain continuous PV inspection readiness and participate in regulatory authority, partner, vendor, and internal audits
• Ensure documentation demonstrates effective oversight of outsourced PV activities
• Support PV system documentation and regulatory requirements, including the PSMF where required
• Develop and maintain SDEAs and pharmacovigilance provisions in licensing, distribution, co-development, and commercialization agreements
• Establish responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance
• Represent the company on joint safety committees and alliance governance forums
• Monitor partner compliance with contractual PV obligations and implement corrective actions
• Maintain current knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other relevant health authorities
• Ensure PV processes remain compliant as products transition from investigational to marketed status and expand geographically
• Support health authority meetings and responses to regulatory questions regarding product safety and benefit-risk

Director – Senior Director, Pharmacovigilance Operations

Manager

• Plan and deliver statistical programming for assigned studies supporting clinical trials, regulatory submissions, publications, and ad hoc analysis requests.
• Track programming timelines and flag risks to the Director.
• Create or oversee CDISC-compliant SDTM and ADaM datasets and perform conformance checks using tools such as Pinnacle 21.
• Develop and validate TLFs and analysis datasets using SAS and R.
• Perform independent quality control of programming produced by others, including cross-language validation where appropriate.
• Assign and review work of internal and CRO programmers; provide direction, feedback, and mentoring.
• Review CRO deliverables, specifications, and documentation for quality and standards compliance.
• Participate in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics.
• Write and maintain batch scripts to schedule SAS and R jobs and distribute reports.
• Prepare programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.
• Contribute to SAS macros, R functions, standards, templates, SOPs, and cross-functional initiatives.
• Provide input on programming tools and infrastructure needs and work with IT as needed.

Manager, Statistical Programming

QA Engineer

• Lead validation planning, execution, and documentation for new and existing systems, including EDMS, QMS, ERP, and RIM
• Create, execute, and approve validation deliverables, including validation plans, risk assessments, requirements, test scripts, trace matrices, and summary reports
• Identify opportunities to streamline and scale validation processes for a small, fast-growing company
• Ensure data integrity principles are incorporated into computerized system processes
• Support vendor qualification and inspection activities
• Lead ongoing system lifecycle maintenance, including risk assessments, change controls, audits, and periodic reviews
• Manage vendor contracts and licensing for computer systems where applicable
• Work with IT to support and improve end users’ computer systems experience
• Collaborate across QA, Clinical, Commercial, IT, Finance, and vendors
• Maintain the validated state of QA computer systems through documentation, periodic reviews, project management, inspection support, and presentations

Director – Senior Director, Pharmacovigilance Operations

Manager, Statistical Programming

Associate Director – QA Computer Systems