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Posted: Saturday, January 13, 2018 10:16 AM

Requisition ID 53215BR
Title Safety Intake Specialist
Job Category Regulatory
Job Description
Responsible for the receipt, documentation and triage of all inbound safety information, including serious and non:serious adverse events, for Novo Nordisk Inc.'s (NNI) US marketed products (drugs and devices). Also responsible for ensuring compliance with all internal and external (e.g. Food and Drug Administration (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, Medical Information, Field Sales, Supply Chain, 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: 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 non:serious adverse events and technical complaints associated with NNI products. Perform data entry of technical complaints and other safety information. Faciliatate customer replacements and refunds; generate acknowledgement letters. Scan and archive incoming mail containing safety information. Perform triage, case classification and team assignment. Handle escalated calls for non:serious adverse events and technical complaints. Support Case Handling team with reconciliation with vendors and partners. Assist with training of new hires; mentor new hires. Call monitoring of Product Safety's non:serious adverse event calls and Patient Centric Customer Care's safety calls. Process feedback from Customer Complaint Center and Clayton. Quality review of technical complaint reports. Assist with workload coordination/distribution. Support the identification of trends and implementation of corrective actions for issues identified during call monitoring, quality review of technical complaint reports, and feedback from Customer Complaint Center and Clayton. Perform quality checks of cases flagged as incidental/non:cases; support the identification of trends and implementation of corrective actions. Serve as Subject Matter Expert during audits/inspections for serious and non:serious 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 preferred); relevant experience may be substituted for degree, when appropriate (e.g. Registered Nurse with clinical experience)
* A minimum of 4 years of progressively responsible, relevant experience; Product Safety experience preferred
* A minimum of 2 years of Customer Service experience required
* Exceptional knowledge of medical 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


• Location: Jersey Shore, princeton

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