Manager - Patient Safety

About the Department                                                                                                                                               

The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-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

To ensure compliance with all Federal regulations and company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI) US marketed products (drugs and devices).

 

To support workflow management and coordination of all daily operations of Product patient Safety's case processing activities, which include the receipt, documentation, triage, case review, and quality assessment of all inbound safety information, including serious and non-serious adverse events, for NNI US marketed products (drugs and devices).

 

To contribute and support activities related to compliance reporting and quality tasks in order to ensure consistency and compliance in all activities performed by Patient Safety.

 

Relationships

Reports to Patient Safety Director. Works closely with, including not limited to the following: all units in Patient Safety, Global Safety, Medical Information, Field Sales, Customer Complaints Center, GXP Support, Legal, Compliance, Commercial, Finance and Patient Centric Customer Care. External relationships include interactions with patients, caregivers, healthcare professionals, FDA, NNI business partners, and vendors.

 

Essential Functions

• Ability to perform all responsibilities of more junior case processing staff; perform any or all of these activities when needed to support the team, including but not limited to processing of serious and non-serious adverse events and associated technical complaints and analysis results related to marketed NNI products into the local intake tool, complaint and global safety databases
• Contribute and support the evaluation of daily GXP lists for regulatory submission of individual case safety reports from both post-marketing and clinical trial sources to the FDA
• Assist with preparation of periodic and annual reports for submission to the FDA
• Monitor the quality of Product patient Safety deliverables and provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure case quality as per NN standard
• Support triage, case classification and case assignment, handle workflow case allocation, or assist with management of workload coordination/distribution when needed
• Handle escalated calls for all case types and investigate solutions for unique situations by collaborating across the
• Organization
• Support Patient Safety’s responsibilities and maintain oversight toward Patient Support Programs, Market Research Programs, call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, and supplier relations
• In collaboration with Patient Safety training specialist and people managers, support internal and external training activities such as safety reporting training for all employees in NNI, or external stakeholders
• Serve as Subject Matter Expert during audits/inspections on all case processing and compliance reporting processes and take lead role in the audit/inspection process (e.g., prepare pre-audit requests, perform document review, coach auditees, manage document requests, front room auditee, messenger, scribe)
• Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions
• Ensure timely registration of deviation(s) and participate, as needed, in defining and driving the implementation of correction, corrective and preventive actions in response to quality and/or compliance issues
• Collaborate with other units within Patient Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management. Directs employees on proper root cause analysis, identification, documentation, co