Altimmune, Inc.

Operations

• Provide day-to-day oversight of the company's Pharmacovigilance system and delegated PV activities
• Oversee global pharmacovigilance activities, including case processing, reporting, literature surveillance, safety data reconciliations, and outsourced PV services
• Review safety data for quality, completeness, and consistency across clinical studies
• Monitor PV performance metrics, quality indicators, quality trends, and compliance metrics
• Identify, investigate, and escalate PV compliance issues
• Support implementation of new products, partners, and business initiatives affecting PV activities
• Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties
• Maintain vendor performance and contractual/PVA obligations and coordinate governance reviews
• Coordinate inspection readiness, regulatory inspections, vendor audits, inspection responses, commitments, and follow-up activities
• Support the pharmacovigilance quality framework and monitor deviations, quality events, CAPAs, audits, inspections, and corrective actions
• Oversee PV training governance and maintain PV procedures, work instructions, governance records, and evidence repositories
• Support development, implementation, and maintenance of Pharmacovigilance Agreements and partner governance documents
• Serve as operational liaison and PV project manager between Pharmacovigilance and internal stakeholders
• Lead PV governance meetings, coordinate cross-functional safety deliverables and timelines, and present compliance trends, risks, and recommendations to PV leadership
• Support strategic initiatives and organizational change activities impacting the PV system

Explore Director, Pharmacovigilance Operations at Altimmune, Inc.. Review requirements and application details.

Director, Pharmacovigilance Operations

Director

• Own the drug substance CMC strategy from development through late-stage clinical and commercial-readiness activities.
• Lead peptide API process development, optimization, scale-up, robustness, characterization, and technology transfer.
• Provide technical leadership and oversight of CDMO development plans, manufacturing campaigns, investigations, deviations, change controls, CAPAs, risk assessments, and continuous improvement.
• Establish phase-appropriate QbD-based process control strategies.
• Drive process characterization, validation strategy, PPQ readiness, continued process verification planning, and commercial manufacturing readiness.
• Lead drug substance comparability assessments and technical risk evaluations.
• Partner with Process Analytics on analytical method development, validation, transfer, trending, and data interpretation.
• Author, review, and approve CMC content for regulatory submissions and responses; support Health Authority interactions.
• Align manufacturing plans, material availability, timelines, and CDMO deliverables with program and clinical supply requirements; mitigate risks.
• Build and manage relationships with external manufacturing partners, including governance, escalation, performance oversight, and supplier evaluation.
• Lead cross-functional technical teams and communicate strategy, risks, decisions, and recommendations to CMC and senior leadership.
• Mentor and develop CMC scientists.

Explore Senior Director, Drug Substance Development at Altimmune, Inc.. Review requirements and application details.