Head of US Risk Management & Product Safety (REMS)

Novartis•East Hanover, NJ

12h

About The Position

As the Head of US Risk Management & Product Safety (Risk Evaluation and Mitigation - REMS), you will lead the US safety strategy for complex and high-impact medicines. You will be responsible for the end-to-end design and execution of Risk Evaluation and Mitigation Strategies, influencing how patients safely access innovative therapies across the United States. In this role, you will partner with the FDA and senior cross-functional leaders, ensure inspection-ready operations, and translate evolving regulatory expectations into practical, patient-centric risk management to enable confident, compliant commercialization.

Requirements

Fluent English (both spoken and written).
A Bachelor’s degree required.
10+ years' experience in risk management operations, including risk management planning and leadership experience in the pharmaceutical industry required.
4+ years of REMS management and/or risk management experience in a matrix role that encompasses leading cross-functional teams across all areas of an organization.
Strong knowledge of FDA REMS requirements, US PV regulations, risk minimization strategies, and audit/inspection management.
Proven leadership in cross-functional settings; excellent communication, influencing, collaboration, and decision-making skills.
Strong executive presence with excellent interpersonal, verbal, and written communication abilities, organizational acumen, and the capability to manage multiple high‑priority projects simultaneously.
Proven expertise leading large-scale, strategic initiatives related to drug development, risk management and regulatory requirement.
Deep understanding of risk management principles and best practices for REMS development implementers, and experience implementing risk management practices and/or managing risk in complex and/or conflict related environments.

Nice To Haves

An advanced degree is preferred (PharmD, M.D, PHD).
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.