US-NJ, Safety Intake Specialist Job 450940600A0-MZ
|Requisition ID 53215BR|
Title Safety Intake Specialist
Job Category Regulatory
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 & 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.
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.
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 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 - M/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.
Department CMR - PRODUCT SAFETY (4)
Position Location US - Plainsboro, NJ
State/Provinces US - NJ
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com