Head of US Risk Management & Product Safety

East Hanover, NJ - USA

Yearly Salary: $ 176400 - 327600

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

The Head of US Risk Management & Product Safety (REMS) provides strategic leadership oversight and execution of US Risk Evaluation and Mitigation Strategies (REMS) and local product safety activities across the product lifecycle. This role ensures high quality implementation of risk management programs operational excellence regulatory compliance and optimal patient safety outcomes. The position partners cross functionally with Medical Regulatory Commercial Quality and Global Safety teams and serves as the primary US authority on REMS and product safety.

Job Description

#LI-Hybrid

Location: East Hanover NJ

Key Responsibilities:

1. REMS Strategy & Leadership

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 crossfunctional project and product teams across the lifecycle to develop and operationalize evidencebased risk management solutions including enhanced pharmacovigilance and riskminimization activities.

2. REMS Operational Oversight

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.

3. US Local Product Safety Management

Serve as the primary US authority for product safety inquiries escalations and Health Authority interactions across the lifecycle.
Oversee safetyrelated US labeling (USPI Medication Guides REMS language) and ensure timely submission of required US aggregate reports.

4. Regulatory Compliance & Quality Oversight

Ensure inspection and audit readiness for all REMS and US productsafety 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 sciencebased patientcentric risk management approaches.

Essential Requirements:

A Bachelors 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 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 Requirements:

Familiarity with safety databases REMS platforms and data analytics tools.

The salary for this position is expected to range between $176400 and $327600 per year.

The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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

$176400.00 - $327600.00

Skills Desired

Auditing Compliance Risk Corrective Action Plans (Cap) Cross-Functional Teams Drug Development Due Diligence Global Project Management Internal Audit Regulatory Reporting Risk Assessment Risk Management

Required Experience:

Director

Job Description SummaryThe Head of US Risk Management & Product Safety (REMS) provides strategic leadership oversight and execution of US Risk Evaluation and Mitigation Strategies (REMS) and local product safety activities across the product lifecycle. This role ensures high quality implementation o...