Pharmacovigilance Quality & Compliance Lead

Socket.dev; East Hanover (NJ); On-site; USD 120,000 - 222,000; Full time

Job summary

Novartis in East Hanover, NJ seeks a Senior Pharmacovigilance Quality professional to lead quality and compliance initiatives across Patient Safety and PV operations. You will drive inspection readiness, guide regulatory compliance, and collaborate with global teams to uphold patient safety standards.

This role focuses on managing deviations and CAPAs, analyzing quality trends, and delivering continuous improvement across regulatory frameworks.

Qualifications

• Advanced Pharmacovigilance knowledge including compliance and inspection readiness.
• Master of Science, Doctor of Pharmacy, or equivalent.
• Significant experience in Pharmacovigilance quality and regulatory functions.
• Strong understanding of global PV regulations and industry standards.
• Proven experience supporting audits, inspections, and investigations.
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong analytical and problem-solving capabilities; excellent written and verbal English.

Responsibilities

• Lead quality and compliance initiatives across Patient Safety and Pharmacovigilance operations.
• Drive continuous improvement programs to strengthen quality systems and processes.
• Support inspection readiness activities and regulatory health authority inspections.
• Monitor compliance metrics and identify opportunities for risk mitigation.
• Provide expert guidance on Pharmacovigilance regulations, policies, and procedures.
• Partner with stakeholders to implement quality improvements and compliance strategies.
• Manage deviation, corrective action, and preventive action activities effectively.
• Analyze quality trends and develop actions to improve performance.
• Contribute to governance activities and quality review processes.
• Support training initiatives to enhance quality and compliance awareness.

Skills

Pharmacovigilance

Quality systems

Audit readiness

Regulatory intelligence

Stakeholder management

Cross-functional collaboration

English communication

Education

Master of Science or Doctor of Pharmacy

Job description

Novartis in East Hanover, NJ seeks a Senior Pharmacovigilance Quality professional to lead quality and compliance initiatives across Patient Safety and PV operations. You will drive inspection readiness, guide regulatory compliance, and collaborate with global teams to uphold patient safety standards.

This role focuses on managing deviations and CAPAs, analyzing quality trends, and delivering continuous improvement across regulatory frameworks.