Director, Pharmacovigilance Operations

Altimmune; Morristown (NJ); Híbrido; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Regulatory compliance training

Descripción de la vacante

Altimmune seeks a Director of Pharmacovigilance Operations to oversee the PV system and ensure compliance with regulatory requirements and partner obligations. This role manages vendors, inspection readiness, quality oversight, and governance processes across PV activities, partnering with Regulatory Affairs, QA, Medical Affairs, Commercial, Clinical, and external service providers.

Depending on location, the role may be hybrid or remote.

Formación

• Bachelor's degree in science or health field with pharmaceutical industry background.
• 10+ years in Drug Safety/PV operations in biotech.
• Experience with vendor oversight, PV Agreements, compliance monitoring, inspection readiness.
• Knowledge of FDA, ICH and global PV requirements.
• Experience supporting FDA inspections.
• Deep PV science knowledge and regulatory oversight.
• Strong analytical, communication, organizational and project management skills.

Responsabilidades

• Oversee global PV activities including case processing, reporting, literature surveillance and safety data reconciliations.
• Monitor PV performance metrics and quality indicators; track trends and compliance.
• Identify, investigate and escalate PV compliance issues.
• Govern vendor oversight for PV vendors, CROs, license partners and other external parties; manage contracts and oversight.
• Coordinate inspection readiness activities for FDA/Health Canada and partners.
• Lead PV governance meetings and cross-functional safety deliverables and timelines.

Conocimientos

Analytical skills

Communication skills

Organizational skills

Project management

Leadership

Cross-functional collaboration

Educación

Bachelor's degree in science/health

Descripción del empleo

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 studies
• Monitor PV performance metrics, key quality indicators, quality trends, and compliance metrics

• Identify, investigate, and elevate 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 Governance

• Lead 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 Compliance

• Coordinate 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 Oversight

• Support 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 Documentation

• Oversee 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 Processes

• Support 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 Collaboration

• Serve 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 timelines
• Present compliance trends, risks, and recommendations to PV leadership
• Support strategic initiatives and organizational change activities impacting the PV system

Job 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 management
• Knowledge of FDA, ICH, and global pharmacovigilance requirements
• Experience supporting FDA inspections
• A minimum of 10+ years of experience in Drug Safety/PV operations in the biotech industry
• Experience within specialty pharmaceutical, biotechnology, or highly outsourced pharmacovigilance environments.
• Deep knowledge of PV science, operations, and global PV regulations
• Technical: PV regulations and compliance; vendor governance; inspection readiness, quality systems; risk management; PV agreements; compliance metrics and oversight
• Strong analytical, communication, organizational, and project management skills

Altimmune 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.