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
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.
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.
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
