Specialist - Case Processing - Multiple Positions Job:
Novo Nordisk

Novo Nordisk
plainsboro New Jersey
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (NNI) 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 Food & Drug Administration (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, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for Novo Nordisk Inc.’s (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.

Reports to Product Safety Management. Daily internal interactions with personnel from Product Safety, Clinical Trial Management (CTM), 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
  • Ability to perform all responsibilities of more junior staff, including but not limited to: Full processing of adverse events and associated technical complaints and analysis results related to marketed NNI products into the complaint and global safety databases, including but not limited to: Duplicate searches; Product coding; MedDRA coding; Narrative generation
  • Labeling assessment according to the current approved product label
  • Receive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requests
  • Perform verification of adverse events and associated technical complaints and provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure excellent case quality
  • Manage all outbound letters and inbound letters
  • Collect and document information received during outbound follow-up calls
  • Generate acknowledgement and follow-up letters
  • Perform triage, case classification and case assignment
  • Handle escalated calls for non-serious adverse events and technical complaints
  • Assist with training of new hires; mentor new hires
  • Perform reconciliations
  • Assist with workload coordination/distribution
  • Support the identification of trends and implementation of corrective actions for issues identified during verification
  • Coordinate the generation of all investigation result letters for patients and healthcare professionals who report product quality issues; oversee junior staff assigned to this activity
  • Coordinate and perform clean-up of adverse event cases as part of preparation for the Periodic Safety Update Report (PSUR) and Periodic Adverse Drug Experience Report (PADER)
  • Perform case corrections to all cases with errors found during Global Safety’s Quality Control (QC) check and weekly non-serious medical reviews, and disseminate learnings to the team
  • Serve as Subject Matter Expert during audits/inspections for case handling
  • 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 and support implementation of solutions
  • Assist with department related projects

Physical Requirements
0-10% overnight travel required. May be required to work company holidays and weekends.

  • Bachelor’s degree required (in medical or science-related discipline)
  • A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required
  • A minimum of 2 years of Customer Service experience preferred
  • Exceptional knowledge of medical and pharmacovigilance terminology required
  • Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)
  • Experience with audits/inspections preferred
  • Analytical thinking skills required
  • Proficiency in Windows, Microsoft Word, Excel and Outlook required
  • Experience with a Call Center and Drug Safety database preferred
  • Strong oral and written communication skills required
  • Ability to work with sensitive or confidential information required
  • Strong attention to detail required
  • Ability to handle multiple priorities and demands in a fast-paced environment required
  • Strong planning, organizational and time management skills required
  • Ability to interact with various levels of the organization required
  • Ability to form strong working relationships with stakeholders required
  • Bi-lingual (Spanish-English) a plus

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Requisition ID: 59858BR
State/Provinces: Plainsboro
Job Category: Regulatory

Basic Qualifications