Head of US Risk Management & Product Safety (REMS)

Job Description Summary

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 commerciallyfeasibleREMS 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 Local Product Safety Management

• Oversee US safety related labeling (USPI Medication Guides REMS safety language) and overseetimelyaccuratesubmission 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

• Maintainreadiness 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.

• Participatein FDA interactions REMS negotiations advisory boards and industry forums.

Essential Requirements:

• Fluent English (both spoken and written).

• A Bachelors degree required. An advanced degree is preferred (PharmD M.D PHD).

• 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 highpriority 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.

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 $204400 and $379600 per year.

The final salary offered isdeterminedbased on factors like relevant skills andexperience andmay be reviewed periodically. Novartis may change the published salary range based on company and market factors. Compensation includesa performance-based cashincentiveand eligibility for annual equity awards.

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

Join Novartis and play a defining role in advancing patient safety and regulatory excellence in the United now to be part of a purpose-driven organization reimaginingmedicinefor patients worldwide.

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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired