Pharmacovigilance Quality & Compliance Lead

Novartis Group Companies; East Hanover (NJ); Hybrid; USD 120,000 - 222,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Generous time off package

Job summary

Novartis Group of Companies in East Hanover, New Jersey, is seeking an experienced Pharmacovigilance Quality Lead to ensure compliance, strengthen quality systems, and support inspection readiness across Patient Safety and Pharmacovigilance operations.

You will drive continuous improvement initiatives, influence strategic quality programs, and partner with cross-functional teams to safeguard patient safety and regulatory excellence.

Qualifications

• Advanced Pharmacovigilance knowledge including compliance, quality, inspection readiness and regulatory intelligence.
• Significant experience in Pharmacovigilance quality, compliance, or related functions.
• Strong ability to manage stakeholders and collaborate cross-functionally.
• Excellent written and verbal communication skills in 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 knowledge

Stakeholder management

Analytical thinking

English communication

Education

Master of Science or Doctor of Pharmacy

Job description

Novartis Group of Companies in East Hanover, New Jersey, is seeking an experienced Pharmacovigilance Quality Lead to ensure compliance, strengthen quality systems, and support inspection readiness across Patient Safety and Pharmacovigilance operations.

You will drive continuous improvement initiatives, influence strategic quality programs, and partner with cross-functional teams to safeguard patient safety and regulatory excellence.