US Risk & Product Safety Director (REMS)

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation; East Hanover (NJ); Hybrid; USD 204,000 - 380,000; Full time

Job summary

Novartis seeks a Senior Director, US Risk Management & Product Safety in East Hanover, NJ to lead the US safety strategy for high-profile medicines, overseeing REMS design, product safety governance, FDA engagement, and risk management execution.

This role requires a BS in Health Care/Life Sciences, 10+ years PV leadership, 8+ years pharma experience, and deep REMS knowledge; you will partner with senior leaders to shape US risk management strategies.

Qualifications

• Bachelor’s degree in Health Care / Life Sciences; advanced degree preferred (PharmD, PhD, or MD).
• 10+ years of PV leadership experience, including risk management planning and operational execution.
• Minimum of 8 years pharmaceutical industry experience is required.
• Strong knowledge of FDA REMS requirements, US pharmacovigilance regulations, and audit/inspection management.
• Proven leadership, communication, influencing, and decision-making capability.
• Strong executive presence and ability to manage multiple high-priority initiatives.
• Expertise leading large-scale strategic initiatives related to drug development and regulatory requirements.
• Deep understanding of risk management principles and best practices for REMS implementation.

Responsibilities

• REMS Strategy & Leadership: Lead US REMS safety strategy aligned with FDA requirements, global risk management plans, and evolving patient safety priorities.
• REMS Operational Oversight: Manage REMS vendor performance to ensure compliance, high quality training, and robust data integrity.
• US Product Safety Strategy: Oversee US safety labeling and timely submission of US aggregate reports.
• Regulatory Compliance & Quality Oversight: Maintain readiness for inspections and CAPAs to closure; keep current with evolving regulatory requirements.

Skills

PV leadership

FDA REMS requirements

Executive presence

Regulatory compliance

Risk management

Education

Bachelor’s degree in Health Care / Life Sciences

Advanced degree (PharmD, PhD, or MD)

Job description

Novartis seeks a Senior Director, US Risk Management & Product Safety in East Hanover, NJ to lead the US safety strategy for high-profile medicines, overseeing REMS design, product safety governance, FDA engagement, and risk management execution.

This role requires a BS in Health Care/Life Sciences, 10+ years PV leadership, 8+ years pharma experience, and deep REMS knowledge; you will partner with senior leaders to shape US risk management strategies.