Associate 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

Advanced level position expected to perform and aid with coordination of all daily operations within Patient Safety's Case Handling teams, which are responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including serious and non-serious adverse events, for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices) and investigational products. 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 Patient Safety Management. Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care. Daily external interactions with patients, caregivers, health-care professionals and external vendors.

 

Essential Functions

• Ability to perform all responsibilities of more junior 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, complaint and global safety databases, including but not limited to:
• Data entry, duplicate searches, product coding, MedDRA coding, narrative generation, labeling assessment according to the current approved product label
• Support the evaluation of regulatory submission of expedited safety reports from the daily GSP lists
• Participate in PRB meetings for all assigned NN products, as needed
• Receive inbound and make outbound calls for adverse events and technical complaints including handling of refunds and replacement requests
• Perform data entry and review of non-serious adverse events and associated technical complaints and provide ongoing feedback regarding case quality to other case handlers to support their continued development and ensure excellent case quality as per NN standard
• Handle incoming and outgoing follow-up correspondence
• Collect and document information received during outbound follow-up calls
• Perform triage, case classification and case assignment
• Handle escalated calls for all case types
• Assist with training of new hires; mentor new hires
• Assist with management of workload coordination/distribution
• Perform call monitoring as needed
• Serve as Subject Matter Expert during audits/inspections on all Case Handling processes and take an active role in the audit/inspection process (e.g. perform document review, coach auditees, manage document requests, 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
• Build