Director, Patient Safety Medical Review
Location: Plainsboro, United States
Category: Regulatory Affairs & Safety / Pharmacovigilance
Company: Novo Nordisk
Employment Type: Full-Time
About the Department
The Clinical, Medical and Regulatory (CMR) division is one of Novo Nordisk’s most dynamic, collaborative areas. The team contributes to:
Healthcare provider engagement
FDA regulatory strategies
Medical education
Data collection to support product efficacy and development
CMR operates with a patient-focused mission, constantly innovating to improve global quality of life.
Position Summary
The Director of Medical Review oversees the Medical Review team responsible for medical assessment of Individual Case Safety Reports (ICSRs) and other safety reports for Novo Nordisk products.
This role serves as a key leader and advisor within Patient Safety Operations, ensuring compliant handling of all adverse event and product quality complaint cases for post-marketed products within U.S. Operations.
The Director is responsible for strategic leadership, team development, regulatory alignment, and ensuring high-quality safety case processing.
Reporting & Key Relationships
Reports to:
Head of PV Case Management
Works closely with:
Patient Safety
CMR departments
Global Patient Safety & Safety Surveillance
Promotional Review Board
External vendors and case processing hubs (U.S., Mexico City, Bangalore, etc.)
Essential Functions
1. Leadership & Oversight
Lead and manage the Medical Review Case Processing team
Foster a culture of accountability, collaboration, and continuous improvement
Provide expert safety management guidance to cross-functional teams
2. Process Development & Optimization
Oversee medical review of ICSRs, including expectedness/listedness evaluations
Ensure accurate regulatory status assessment for expedited reporting
Develop and optimize procedures for AE/SAE case processing from all report sources
Provide strategic guidance for:
Data acquisition
Seriousness assessment
Coding of drug/event terms
Narrative development
Overall case assessment
Ensure compliance with evolving regulatory guidelines
Manage submission of safety reports (ICSR electronic submissions, IND safety reports, Medical Device Reports, aggregate reports)
3. Labeling & Promotional Review Support
Oversee Patient Safety input to Local Labeling Committees
Ensure Patient Safety participation in Promotional Review Board (PRB) meetings
Participate in the Suspect Product Committee as assigned
4. Global Coordination
Oversight of local PSUR and DSUR activities in collaboration with local and global teams
Coordinate workflow across global hubs and external vendors
Ensure accurate, timely exchange of safety data
5. Risk Management
Serve as escalation point for medical assessment issues
Provide medical strategy for case-related risks
Identify and mitigate safety risks proactively with internal stakeholders
6. Compliance & Quality Assurance
Ensure case processing meets corporate and regulatory standards
Monitor workflow and KPIs for regulatory compliance
Oversee prospective and retrospective quality review of safety cases
7. Regulatory Intelligence & Inspection Readiness
Maintain up-to-date knowledge of FDA, ICH, and global safety regulations
Support internal/external audits and inspections
Ensure documentation and processes are inspection-ready
Physical Requirements
0–10% travel
Development of People
(For supervisory roles)
Ensure direct reports have Individual Development Plans (IDPs) with measurable annual goals
Conduct interim performance reviews
Ensure team readiness for increased responsibility
Reinforce Novo Nordisk policies and culture
Qualifications
Education
MD or equivalent degree required
Experience
10+ years in scientific, regulatory, pharmaceutical, or medical roles
6–8 years of pharmacovigilance experience
Supervisory/team leadership experience preferred
Experience leading therapeutic areas is a plus
Technical & Professional Skills
Expert knowledge of global regulations (FDA, ICH)
Expertise in safety databases and quality systems
Preferred knowledge of Novo Nordisk therapeutic areas:
Diabetes
Obesity
Hemophilia
Growth hormone disorders
Strong communication, organization, workflow, budgeting, and KPI monitoring skills
Compensation & Benefits
Base Salary Range
$181,670 – $317,920
(Varies by experience and organizational factors)
Additional Compensation
Company performance bonus
Long-term incentive packages
Company vehicles (role-dependent)
Benefits
Medical, dental, vision insurance
Life and disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement
Legal, critical illness, identity theft, pet, auto/home insurance
Sick leave, flexible vacation policy, parental leave
Inclusive Hiring
Novo Nordisk is an equal opportunity employer, committed to unbiased and inclusive hiring across all protected characteristics.
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