Senior Director, US Risk Management & Product Safety (REMS)
Novartis
Summary
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.
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.
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.
- Familiarity with safety databases, REMS platforms, and data analytics tools.
Benefits
- Health insurance
- Life insurance
- Disability benefits
- 401(k) with company match
- Generous time off
- Performance-based cash incentive
- Annual equity awards
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.