Strategic US Risk & Product Safety Director

Novartis Group Companies; East Hanover (NJ); Hybrid; USD 204,000 - 380,000; Full time

Job summary

Novartis Group Companies in East Hanover, NJ seeks a Senior Director, US Risk Management & Product Safety to lead US REMS strategy and safety governance for a high-profile portfolio. You will oversee REMS design, vendor performance, FDA engagement, and risk- mitigation execution across complex programs.

You will drive US product safety strategy, labeling oversight, and timely submission of aggregate reports, while partnering with senior leaders to shape REMS and safety risk management across the

Qualifications

• Bachelor's degree in Health Care / Life Sciences; advanced degree preferred (PharmD, PhD, or MD).
• 10+ years PV leadership experience including risk management planning and operational execution.
• Minimum of 8 years pharmaceutical industry experience.
• 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

• Lead the US REMS Safety Strategy, ensuring alignment with FDA requirements and global risk management plans.
• Drive development, approval, and launch of REMS programs including certification and enrollment systems.
• Provide US input into Risk Management Plans and REMS assessments; optimize risk minimization measures.
• Manage REMS vendor performance and ensure compliance, training, and data integrity.
• Oversee execution of REMS commitments and risk mitigation activities.
• Oversee US safety related labeling and submission of US aggregate reports; act as primary safety contact.
• Maintain readiness for inspections, manage CAPAs, and support REMS strategy with regulatory insights.
• Participate in FDA interactions, REMS negotiations, advisory boards, and industry forums.

Skills

PV Leadership

FDA REMS

Risk Management

Regulatory Compliance

Leadership

Communication

Education

Bachelor's degree in Health Care / Life Sciences

Advanced degree preferred (PharmD, PhD, or MD)

Tools

Safety databases

REMS platforms

Job description

Novartis Group Companies in East Hanover, NJ seeks a Senior Director, US Risk Management & Product Safety to lead US REMS strategy and safety governance for a high-profile portfolio. You will oversee REMS design, vendor performance, FDA engagement, and risk- mitigation execution across complex programs.

You will drive US product safety strategy, labeling oversight, and timely submission of aggregate reports, while partnering with senior leaders to shape REMS and safety risk management across the