Novartis
Senior Director, US Risk Management & Product Safety (REMS)
$204K–$380K
East Hanover · Director · Full-time · Posted Sep 10, 2026
- Experience
- 10+ years of PV leadership experience; minimum of 8 years of pharmaceutical industry experience.
- Education
- Bachelor’s degree in Health Care / Life Sciences required; advanced degree preferred (PharmD, PhD, or MD).
About the job
Leads US risk management and product safety strategy for a portfolio of medicines, including REMS design and execution, safety governance, and FDA engagement.
What you'll do
- Lead REMS strategy and oversee development, launch, assessment, and optimization of risk-minimization programs.
- Manage REMS operations, vendors, commitments, safety labeling, and aggregate-report submissions.
- Lead regulatory compliance and inspection readiness, manage corrective actions, and participate in FDA interactions.
What they ask for
- Bachelor’s degree in Health Care / Life Sciences.
- 10+ years of 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.
Nice to have
- Advanced degree (PharmD, PhD, or MD).
- Familiarity with safety databases, REMS platforms, and data analytics tools.
Pay
$204,400 and $379,600 per year (base salary)
Tools
REMS, Risk Management Plans (RMPs), USPI, Medication Guides, PADERs, PBRERs, CAPAs
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