Associate Director, PV Case Operations

• Provide oversight of pharmacovigilance operations and vendor and case processing deliverables
• Ensure staff are prepared to support receipt, processing, distribution and submission of reports from global development programs and globally marketed products
• Ensure inspection readiness and monitor PV deliverable quality and case submission compliance
• Maintain accountability for ICSR quality standards, CAPA ownership, KPI governance and metrics-driven operational oversight
• Ensure accurate and timely case processing deliverables
• Oversee ICSR quality review, including narrative quality, case validity, assessment completeness and source document reconciliation
• Establish tiered quality review frameworks and sampling strategies
• Identify quality trends and root causes and implement remediation
• Support auditors and Health Authority inspectors and respond to audit and inspection findings
• Lead root cause analysis for quality deviations, processing errors and compliance failures
• Develop, own and track CAPAs through closure and conduct effectiveness checks
• Ensure commitments to health authorities, auditors and internal quality teams are met
• Track operational metrics and vendor performance benchmarks
• Develop vendor performance metrics frameworks and conduct governance meetings against contractual SLAs
• Ensure compliance with pharmacovigilance regulations, guidelines, Regeneron SOPs and Working Instructions
• Mentor and support assigned staff
• Communicate deliverables and issues to senior management, internal partners and external partners
• Manage and resolve issues, escalating as needed
• Manage workload to meet compliance objectives and achieve high-quality work

• Minimum Bachelor’s Degree; advanced degree preferred
• 10 years of Pharmacovigilance/Drug Safety/PV Quality experience
• Previous Pharmacovigilance/Drug Safety experience in the pharmaceutical or biotech industry
• Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance for clinical trial and post-marketing environments
• Experience managing and supervising teams on complex projects
• Demonstrated success working on cross-functional teams
• Ability to contribute to and manage organizational projects and goals
• Ability to accomplish tasks through Individual Contributors or other managers
• Ability to travel up to 25%

Demonstrates extensive expertise in pharmacovigilance operations, ensuring compliance with FDA, EU, and ICH guidelines while maintaining high-quality standards in case processing and vendor management. Proven ability to lead teams, manage complex projects, and communicate effectively with internal and external stakeholders.

• Pharmacovigilance Operations Oversight
• ICSR Quality Standards Management
• Regulatory Compliance Knowledge
• Team Leadership and Mentoring
• CAPA Development and Tracking

• Pharmacovigilance
• Drug Safety
• Quality Assurance
• Case Processing
• Root Cause Analysis
• KPI Governance
• Metrics-Driven Oversight
• Audit Support
• Regulatory Compliance
• Vendor Performance Management

• Communication
• Problem-Solving
• Team Collaboration
• Project Management
• Issue Resolution

• FDA Guidelines
• EU Regulations
• ICH Guidelines
• Clinical Trials
• Post-Marketing Surveillance
• CAPA
• SOPs
• Quality Metrics
• Pharmaceutical Industry
• Biotech Industry