Manager - Patient Safety - Team Lead

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 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

Advanced level position expected to perform all daily operations of Patient Safety's Case processing Team, which is responsible for the receipt, documentation, triage, case review and quality assessment of all inbound safety information, including serious and non-serious adverse events and technical complaints, for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices). 
•    Provide day to day management of the Case Processing team
•    Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records by providing guidance, training and mentorship to all team members
 

Relationships

Reports to Director, Patient Safety Case Management 
•    Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Supply Chain, Customer Complaints Center, Patient Centric Customer Care, and Global safety.
•    Daily external interactions with patients, caregivers, health-care professionals and external vendors.
 

Essential Functions

• Ability to perform all responsibilities of more junior case processing staff, 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,
• Handle escalation calls from HCPs and consumers
• Perform triage, case classification and case assignment, and handle workflow case allocation and oversight
• Assist with training of new hires within PS and suppliers as needed. Support mentorship activities for case processing
• Oversight of  call monitoring
• Serve as Subject Matter Expert during audits/inspections on all Case Handling processes and take an active role in the audit/inspection process
• 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
• Serve as Case Handling Team’s Argus Workflow Manager
• Review and collect Case handling metrics and provide analysis and presentation.
• Provide and conduct analysis and processing of Case Handling Key Performance Indicator (KPI) data received from Global Safety
• Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutions
• Lead departmental related projects
• Provide overall management of the team in coordination with PS Management Team (e.g. participate in new candidate interviews, workload coordination, attending meetings and assisting with resulting actions which impact the team)
• Serve as member of the Patient Safety Management team

 

Physical Requirements

0-10% overnight travel required.

 

Development of People

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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.

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Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

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Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

 

Qualifications