Associate Director, PV Case Operations

Jobtailor; Massachusetts; On-site; USD 140,000 - 210,000; Full time

Job summary

Jobtailor is seeking a Senior Pharmacovigilance Quality Leader to oversee global PV operations, case processing standards, and vendor management. You will drive inspection readiness and ensure high-quality ICSR deliverables across development programs and marketed products.

You will mentor teams, implement CAPA strategies, and partner with internal and external stakeholders to sustain regulatory compliance with FDA, EU, and ICH guidelines.

Qualifications

• Minimum Bachelor’s Degree; advanced degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/Quality experience.
• Previous Pharmacovigilance/Drug Safety in pharma/biotech industry.
• Knowledge of FDA, EU and ICH guidelines governing pharmacovigilance.

Responsibilities

• Oversee pharmacovigilance operations and case processing deliverables.
• Ensure inspection readiness and regulatory compliance across programs.
• Lead CAPA development and tracking through closure with effectiveness checks.
• Mentor staff and manage vendor performance; communicate with stakeholders.
• Support audits/inspections and respond to findings.

Skills

Pharmacovigilance Oversight

ICSR Quality Management

Regulatory Compliance

Team Leadership

CAPA Development

Vendor Management

Audit Support

Cross-functional Collaboration

Education

Bachelor’s Degree

Advanced degree preferred

Job description

• 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

Requirements

• 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%

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

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

Soft Skills

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

Industry Keywords

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