Director, Pharmacovigilance Operations
About The Position
The Director, Pharmacovigilance Operations provides day-to-day oversight of Altimmune’s Pharmacovigilance (PV) System and ensures delegated PV activities comply with applicable regulatory requirements, company procedures, and partner obligations. The role serves as the operational governance lead for the PV system, overseeing vendors, inspection readiness, compliance monitoring, training governance, PV agreement implementation, quality oversight, and key PV governance processes. It partners with Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Clinical, and external service providers to advance regulatory strategy, execution, and compliance. The position reports to the Senior Director, Safety and Pharmacovigilance. Depending on location, it may be hybrid or remote and may require travel as business needs dictate.
Requirements
- Bachelor's degree, preferably in a science or health-related field.
- Pharmaceutical industry background and demonstrated 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 knowledge of PV regulations and compliance, vendor governance, inspection readiness, quality systems, risk management, PV agreements, and compliance metrics and oversight.
- Strong analytical, communication, organizational, and project management skills.
Responsibilities
- Oversee delegated global pharmacovigilance activities, including case processing, reporting, literature surveillance, safety data reconciliations, and other outsourced PV services.
- Review safety data for quality, completeness, and consistency across clinical studies.
- Monitor PV performance metrics, key quality indicators, quality trends, and compliance metrics; 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.
- Lead oversight of PV vendors, CROs, license partners, patient-support service providers, and other external parties.
- Maintain oversight of vendor performance and contractual and PV Agreement obligations; coordinate governance reviews and performance discussions; and escalate significant concerns.
- Support due diligence, onboarding, transition, and oversight activities for new vendors and partners.
- Coordinate ongoing inspection-readiness activities and maintain readiness for FDA, Health Canada, partner, and internal audits.
- Support regulatory inspections and vendor audits; coordinate inspection responses, commitments, and follow-up; and maintain inspection-support materials and evidence retrieval processes.
- Support implementation and maintenance of the PV 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.
- Oversee PV training governance and ensure training requirements are established and maintained for personnel and applicable external parties.
- Support maintenance of PV procedures, work instructions, governance records, and related documentation, including inspection-ready documentation and evidence repositories.
- Support development, implementation, and maintenance of Pharmacovigilance Agreements (PVAs) and related partner governance documents.
- Monitor obligations arising from PVAs and related contracts and coordinate periodic reviews and updates of partner oversight documentation.
- Serve as the 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 affecting the PV system.
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What This Job Offers
Job Type
Full-time
Career Level
Director
