Patient Safety Senior Associate

4 weeks ago

Plainsboro, New Jersey, United States Novo Nordisk Full time

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

Responsible for the receipt, documentation, triage and quality assessment of inbound safety information, including adverse events and technical complaints, for Novo Nordisk Inc.'s (NNI) US marketed products (drugs and devices). 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 information.

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.

Essential Functions

Ability to perform all responsibilities of more junior staff, including but not limited to: Processing of 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:Duplicate searchesProduct codingMedDRA codingNarrative generationLabeling assessment according to the current approved product labelReceive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requestsHandle escalated callsHandle incoming and outgoing follow-up correspondenceScan and archive incoming mail containing safety informationCollect and document information received during outbound follow-up callsPerform triage, case classification and case assignmentPerform reconciliationsPerform data entry and review of 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 qualityAssist with training of new hires; mentor new hiresGeneration of investigation result letters for patients and healthcare professionals who report product quality issuesPerform call monitoring for Patient Safety calls and provide feedback to team membersProcess feedback from Customer Complaint Center and Clayton; provide feedback to case handlersServe as Subject Matter Expert for adverse events and technical complaints during audits/inspectionsAssist with workload coordination/distributionBuild customer loyalty by providing high quality customer serviceProvide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scriptsIdentify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and support implementation of solutionsAssist with department related projects Physical Requirements 0-10% overnight travel required; May be required to work company holidays and weekends. QualificationsBachelor'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 2 years of progressively responsible, relevant experience; relevant pharmacovigilance, safety experience (including MedDRA coding and adverse event identification) preferredA minimum of 2 years of Customer Service experience preferredStrong knowledge of pharmacovigilance terminology requiredKnowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)Experience with audits/inspections preferredAnalytical thinking skills requiredProficiency in Windows, Microsoft Word, Excel and Outlook requiredExperience with a Call Center and Drug Safety database preferredStrong oral and written communication skills requiredAbility to work with sensitive or confidential information requiredStrong attention to detail requiredAbility to handle multiple priorities and demands in a fast-paced environment requiredStrong planning, organizational and time management skills requiredAbility to interact with various levels of the organization requiredAbility to form strong working relationships with stakeholders requiredBi-lingual (Spanish-English) a plus We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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