Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.Summary of Position:The Director, Pharmacovigilance Operations provides day-to-day oversight of the company's Pharmacovigilance (PV) System and ensures delegated PV activities comply with applicable regulatory requirements, company procedures, and partner obligations.This position serves as the operational governance lead for the PV system and oversees vendors, inspection readiness, compliance monitoring, training governance, PV agreement implementation, quality oversight activities, and key pharmacovigilance governance processes. Partners cross-functionally with Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Clinical, and external service providers to drive regulatory strategy, execution, and compliance.This position reports to the Senior Director, Safety and Pharmacovigilance, and, depending on location, may be hybrid or remote and may require travel as business needs dictate.Essential Functions:PV Operations Oversight:Provide oversight of delegated global pharmacovigilance activities, including case processing, reporting, literature surveillance, safety data reconciliations, and other outsourced PV services.Safety data review for quality, completeness, and consistency across clinical studiesMonitor PV performance metrics, key quality indicators, quality trends, and compliance metricsIdentify, investigate, and escalate actual or potential PV compliance issues.Coordinate review and follow-up of operational trends and performance indicators.Support implementation of new products, partners, and business initiatives affecting PV activities.Vendor and Partner GovernanceLead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties.Maintain oversight of vendor performance and contractual/PVA obligations.Coordinate periodic governance reviews and performance discussions.Escalate significant compliance, quality, or operational concerns.Support due diligence, onboarding, transition, and oversight activities for new vendors and partners.Inspection Readiness and ComplianceCoordinate ongoing inspection-readiness activities.Maintain readiness for FDA, Health Canada, partner, and internal audits.Support regulatory inspections and vendor audits.Coordinate inspection responses, commitments, and follow-up activities.Maintain inspection-support materials and evidence retrieval processes.PV Quality System OversightSupport implementation and maintenance of the pharmacovigilance quality framework.Monitor deviations, quality events, CAPAs, audits, inspections, and corrective actions.Support periodic review of PV system health and compliance trends.Participate in risk assessments and continuous improvement initiatives.Training and Controlled DocumentationOversee PV training governance processes.Ensure appropriate training requirements are established and maintained for personnel and applicable external parties.Support maintenance of PV procedures, work instructions, governance records, and related documentation.Ensure inspection-ready documentation and evidence repositories are maintained.PV Agreements and Governance ProcessesSupport development, implementation, and maintenance of Pharmacovigilance Agreements (PVAs) and related partner governance documents.Monitor obligations arising from PVAs and related contracts.Coordinate periodic reviews and updates of partner oversight documentation.Leadership and Cross-Functional CollaborationServe as primary operational liaison and PV project manager between Pharmacovigilance and internal stakeholders.Provide leadership for PV governance meetings and oversight reviews and coordinate cross-functional safety deliverables and timelinesPresent compliance trends, risks, and recommendations to PV leadershipSupport strategic initiatives and organizational change activities impacting the PV systemJob Requirements (essential knowledge, skills, and attributes):Bachelor's degree, preferably in a science or health-related field; with pharmaceutical industry background and proven competence in pharmacovigilance Demonstrated experience with vendor oversight; PV Agreements; compliance monitoring; inspection readiness; regulatory reporting requirements; quality systems and CAPA managementKnowledge of FDA, ICH, and global pharmacovigilance requirementsExperience supporting FDA inspections A minimum of 10+ years of experience in Drug Safety/PV operations in the biotech industryExperience within specialty pharmaceutical, biotechnology, or highly outsourced pharmacovigilance environments. Deep knowledge of PV science, operations, and global PV regulationsTechnical: PV regulations and compliance; vendor governance; inspection readiness, quality systems; risk management; PV agreements; compliance metrics and oversightStrong analytical, communication, organizational, and project management skillsAltimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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