Senior Director, US Risk Management & Product Safety (REMS)

Novartis•East Hanover, NJ

27d•$204,400 - $379,600•Hybrid

About The Position

Join Novartis in a pivotal leadership role where patient safety and innovation intersect. As Senior Director, US Risk Management & Product Safety, you will lead the US safety strategy for a portfolio of complex, high-profile medicines, overseeing REMS design, product safety governance, FDA engagement, and risk management execution. This is a rare opportunity to influence how breakthrough therapies reach patients safely, while partnering with senior leaders to shape the future of risk management across the US healthcare landscape.

Requirements

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.
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.

Nice To Haves

Familiarity with safety databases, REMS platforms, and data analytics tools.

Responsibilities

Lead the US REMS Safety Strategy, ensuring alignment with FDA requirements, global risk management plans, and evolving patient safety priorities.
Drive development, approval, and launch of innovative, commercially feasible REMS programs including restricted distribution, prescriber/pharmacy certification, and patient enrollment systems.
Provide US input into Risk Management Plans (RMPs) and REMS assessments; ensuring the implementation of recommendations and continuous optimization of risk minimization measures.
Manage REMS vendor performance (including call centers, specialty pharmacies, prescriber certification platforms) to ensure compliance, high quality training, and robust data integrity.
Oversee execution of REMS commitments and risk mitigation activities.
Oversee US safety related labeling (USPI, Medication Guides, REMS safety language) and oversee timely, accurate submission of US aggregate reports (e.g., PADERs, PBRERs).
Serve as the primary contact for US product safety inquiries, escalations, and Health Authority requests.
Maintain readiness for inspections and audits; manage findings, corrective actions, and CAPAs to closure.
Keep current with evolving regulatory requirements and provide insights to support REMS and safety risk management strategy.
Participate in FDA interactions, REMS negotiations, advisory boards, and industry forums.