Novartis · 14 hours ago
Head of US Risk Management & Product Safety (Risk Evaluation and Mitigation Strategies-REMS)
East Hanover, NJ
Full-time
Onsite
Director/Executive
$176K/yr - $328K/yr
10+ years expNovartis is seeking a Head of US Risk Management & Product Safety to provide strategic leadership and oversight for US Risk Evaluation and Mitigation Strategies (REMS) and local product safety activities. This role involves ensuring the implementation of risk management programs, regulatory compliance, and optimal patient safety outcomes while collaborating with various cross-functional teams.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead the design, regulatory development, and launch execution of innovative REMS programs, ensuring operational feasibility and alignment with commercial strategy through collaboration with cross functional leaders
Design, execute, and continuous improvement of REMS programs that minimize stakeholder burden while enhancing patient safety
Lead cross‑functional project and product teams across the lifecycle to develop and operationalize evidence‑based risk management solutions, including enhanced pharmacovigilance and risk‑minimization activities
Oversee performance and governance of REMS vendors to ensure quality execution, compliance, and data integrity
Ensure accurate, timely compliant execution of REMS commitments and assessments, including monitoring of KPIs and escalation of risks
Serve as the primary US authority for product safety inquiries, escalations, and Health Authority interactions across the lifecycle
Oversee safety‑related US labeling (USPI, Medication Guides, REMS language) and ensure timely submission of required US aggregate reports
Ensure inspection and audit readiness for all REMS and US product‑safety operations; lead response management, corrective actions, and CAPA implementation through closure
Maintain deep expertise in evolving US regulatory and REMS requirements; translate regulatory expectations into operational guidance
Represent the company in FDA interactions, REMS negotiations, advisory committee discussions, and relevant industry forums to advocate for science‑based, patient‑centric risk management approaches
Qualification
Required
A Bachelor's degree required. An advanced degree preferred (PharmD, M.D, PHD)
10+ years' experience in risk management operations, including risk management planning and leadership experience in the pharmaceutical industry required
5+ years of leading REMS programs a matrix role that encompasses managing 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 high‑priority 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
Preferred
Familiarity with safety databases, REMS platforms, and data analytics tools
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A variety of other benefits
A generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
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