Patient Safety Associate

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

Responsible for the receipt, documentation and triage of safety information, including adverse events and technical complaints for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices). Responsible for ensuring compliance is met with all internal and external (e.g. FDA) drug and device safety reporting regulations.

 

Relationships

Reports to Patient Safety Management.

 

Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Customer Complaints Center and Patient Centric Customer Care.

 

Daily external interactions with patients, caregivers, health-care professionals and external vendors.

 

Essential Functions

• Collect and document information received from inbound and outbound contacts (verbal and written communications) from and to healthcare professionals, NNI sales personnel, patients, caregivers and vendors related to adverse events and technical complaints associated with NNI products
• Identification of adverse events and event seriousness, causality and case classification (solicited vs. spontaneous, device vs. drug)
• Perform triage and data entry of adverse events with or without associated technical complaints and other safety information into applicable databases
• Facilitate customer replacements and refunds
• Generation and handling of follow-up letters
• Scan and archive incoming mail containing safety information
• Process feedback from Customer Complaint Center and Clayton; provide feedback to case handlers
• Handle inbound and outbound calls for adverse events with or without associated technical complaints, replacements, and/or refunds, as applicable
• Generation of investigation result letters for patients and healthcare professionals who report product quality issues
• Support audits/inspections as needed
• Build customer loyalty by providing high quality customer service
• Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts
• Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management
• Assist with department related projects

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

• Bachelors degree required, preferably in science or healthcare discipline; relevant experience may be substituted for degree, when appropriate (e.g. Registered Nurse with clinical experience)
• A minimum of 1-year Patient Safety experience preferred with Customer Service experience preferred
• Strong knowledge of medical and