US Risk & Product Safety Director – REMS & FDA Strategy

Novartis; East Hanover (NJ); On-site; USD 204,000 - 380,000; Full time

Job summary

Novartis in East Hanover, NJ, seeks a Senior Director, US Risk Management & Product Safety, to lead the US safety strategy for a portfolio of complex medicines, overseeing REMS design, governance, FDA engagement, and risk mitigation execution.

This role partners with senior leaders to shape REMS and safety risk management across the US healthcare landscape, directing high-priority programs and ensuring compliance, quality, and timely safety communications.

Qualifications

• Bachelor’s degree in Health Care / Life Sciences required; 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.
• Ability to manage multiple high-priority initiatives with executive presence.

Responsibilities

• Lead the US REMS safety strategy aligned with FDA requirements.
• Oversee REMS programs including certification, enrollment systems, and training.
• Manage REMS vendor performance and data integrity.
• Oversee US safety labeling and aggregate reporting (PADERs, PBRERs).
• Serve as primary contact for US product safety inquiries and Health Authority requests.
• Maintain readiness for inspections and CAPA closures.

Skills

Leadership

Communication

Decision making

Influencing

Education

Bachelor's degree in Health Care / Life Sciences

Advanced degree preferred (PharmD, PhD, or MD)

Tools

Safety databases

REMS platforms

Data analytics tools

Job description

Novartis in East Hanover, NJ, seeks a Senior Director, US Risk Management & Product Safety, to lead the US safety strategy for a portfolio of complex medicines, overseeing REMS design, governance, FDA engagement, and risk mitigation execution.

This role partners with senior leaders to shape REMS and safety risk management across the US healthcare landscape, directing high-priority programs and ensuring compliance, quality, and timely safety communications.