Director, Patient Safety Case Management

About the Department

 

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

 

The Position

Responsible for overseeing the end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also involves oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case processing issues and provides support and escalation channels for both internal teams and external stakeholders, including patients and healthcare professionals, with inquiries, case handling issues, and process improvements related to patient safety.

 

Relationships

Reports to the Head of NNI Patient Safety, with cross-functional working relationships within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety, and centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). This role will provide direct guidance to senior managers and managers involved in case triage, case processing and case verification. Works with Vendor leadership and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and other case management leadership team members. External relationships include interactions with patients and healthcare professionals. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.

 

Essential Functions

• Leadership & Oversight
  • Lead and manage the global Case Processing team, fostering a culture of accountability, collaboration, and continuous improvement
  • Provide expert guidance to cross-functional teams regarding safety case management activities
• Process Development & Optimization
  
  • Design, implement, and continuously improve procedures for AE/SAE case processing, including data collection, assignment, coding (drug/event), narrative development, and case assessment
  • Ensure alignment with evolving regulatory requirements and industry best practices
• Global Coordination
  
  • Oversee communication and workflow integration across case processing hubs (U.S., Mexico City, Bangalore) and external vendors/contractors
  • Ensure seamless operations and timely delivery of safety data
• Risk Management
  
  • Act as the primary point of escalation for case-related risks and operational challenges
  • Collaborate with internal stakeholders to proactively identify and mitigate potential issues
• Compliance & Quality Assurance
  
  • Partner with NNI Patient Safety Management to ensure timely and accurate processing of safety information in accordance with corporate standards
  • Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met
• Audit & Inspection Readiness
  
  • Support the preparation and execution of internal and external audits and regulatory inspections
  • Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards

 

Physical Requirements: 0-10% travel required.

 

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all