Director – Patient Safety (Case Management)
Location: Plainsboro, United States
Category: Regulatory Affairs & Safety Pharmacovigilance
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a highly collaborative and diverse unit involved in:
Healthcare provider interactions
Regulatory strategy development with the FDA
Medical education
Data collection supporting product development
Enhancing patient quality of life through innovative solutions
CMR operates with a strong patient-centered focus.
Position Overview
The Director of Case Management is responsible for end-to-end oversight of:
Case Intake
Triage
Case Processing
Vendor oversight
ICSR verification processes
This role ensures efficient safety case operations, supports escalations, drives process improvements, and maintains compliance with global PV standards.
Reporting Structure
Reports to: Head of NNI Patient Safety
Internal Collaboration with:
Intake & Triage
Medical Review
Submissions & Compliance
Global Safety
Training & Documentation
Quality, Contract Management, Digital Enablement
External Interaction with:
Vendors/contractors
Patients and healthcare professionals
Key Responsibilities
1. Leadership & Oversight
Lead the global Case Processing team
Promote a culture of accountability, collaboration, and performance
Guide cross-functional teams in case management activities
2. Process Development & Optimization
Develop and enhance AE/SAE processing workflows
Ensure compliance with regulatory and industry standards
Oversee drug/event coding, narrative development, data acquisition, and assessment
3. Global Coordination
Integrate workflows across hubs:
U.S.
Mexico City
Bangalore
Manage vendor collaborations
Ensure timely processing and delivery of safety data
4. Risk Management
Serve as escalation point for operational and case-handling issues
Identify and mitigate risks with internal partners
5. Compliance & Quality Assurance
Ensure accurate safety data processing aligned with corporate standards
Monitor KPIs and operational performance
Maintain regulatory compliance across workflows
6. Audit & Inspection Readiness
Support internal/external audits and regulatory inspections
Ensure processes and documentation are always inspection-ready
Physical Requirements
Travel: 0–10%
People Development (Supervisory Role)
Ensure all team members have IDPs (Individual Development Plans)
Conduct performance reviews and provide coaching
Enable team growth and capability building
Ensure compliance with Novo Nordisk policies
Qualifications
Required
Bachelor’s degree (Life Sciences/Pharma or related)
10+ years in scientific/regulatory/pharmaceutical areas
5–8 years of pharmacovigilance experience
Experience leading teams and managing operations
Strong understanding of FDA/ICH regulations
Expertise in safety databases, telephony systems, and quality systems
Strong communication and organizational skills
Experience in workflow management, budgeting, and KPI monitoring
Preferred
Advanced degree (MS, PharmD, PhD, MD)
Knowledge of Novo Nordisk therapeutic areas:
Diabetes
Obesity
Hemophilia
Growth hormone disorders
Compensation & Benefits
Base salary range: $181,670 – $317,920
Eligible for company performance bonus
Long-term incentive programs and company vehicle (depending on level)
Benefits include:
Medical, dental, vision
Life & disability insurance
401(k) plan
FSAs
Employee assistance program
Tuition reimbursement
Voluntary insurance options
Time off: sick leave, flexible vacation, parental leave
Inclusion & Equal Opportunity
Novo Nordisk is committed to inclusive hiring practices.
Qualified applicants are considered without discrimination based on:
Race
Ethnicity
Gender or gender identity
Sexual orientation
Disability
Veteran status
National origin
Religion
Special accommodation requests: 1-855-411-5290
(Not for checking application status)
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