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Director, Pharmacovigilance Operations
Altimmune, Inc.. Provide day-to-day oversight of the company's Pharmacovigilance system and delegated PV activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Pharmacovigilance operations, including vendor oversight, compliance monitoring, and regulatory reporting. Proficient in managing quality systems, inspection readiness, and CAPA management within the pharmaceutical industry.
Highest-signal resume keywords
Pharmacovigilance OperationsVendor OversightRegulatory Reporting RequirementsInspection ReadinessCAPA Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
PharmacovigilanceCase ProcessingSafety Data ReconciliationQuality SystemsCompliance MonitoringRisk ManagementPV AgreementsQuality MetricsData AnalysisRegulatory Compliance
Soft Skills
Analytical SkillsCommunication SkillsOrganizational SkillsProject Management Skills
Industry Keywords
FDAICHBiotech IndustrySpecialty PharmaceuticalGlobal PharmacovigilanceCompliance MetricsVendor GovernanceQuality IndicatorsSafety DataPharmacovigilance Framework
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Bachelor's degree, preferably in a science or health-related field
- 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
- 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
- Knowledge of 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
Benefits
Comp & perks- Work from home flexibility
- Hybrid or remote work arrangement depending on location
- Travel as business needs dictate