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

Novartis Group Companies; East Hanover (NJ); On-site; 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

Job Description Summary

Location: East Hanover, NJ

#LI-Hybrid

Relocation Support: Novartis is unable to offer relocation support - please only apply if this location is accessible to you

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.

Job Description

Major accountabilities:

1. REMS Strategy & Leadership

• 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.

2. REMS Operational Oversight

• 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.

3. US Product Safety Strategy

• 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.

4. Regulatory Compliance & Quality Oversight

• 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.

Essential 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.

Desirable Skills:

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

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $204,400 and $379,600 per year.

The final salary offered is determined based on factors like relevant skills and experience and may be reviewed periodically. Novartis may change the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and eligibility for annual equity awards.

US-based eligible employees receive a comprehensive benefits package including health, life, disability benefits, 401(k) with company match, and generous time off.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

204,400.00 - 379,600.00

Skills Desired

• Clinical Research
• Clinical Trials
• Functional Teams (Inactive)
• Leadership
• Medical Strategy (Inactive)
• Process Safety Management
• Regulatory Compliance
• Risk Management
• Safety Science