- A Bachelor's degree is required (in medical or science-related discipline); relevant experience may be substituted for degree, when appropriate
- 6 years of progressively responsible, relevant pharmacovigilance experience preferred (including MedDRA coding and adverse event reporting
- Experience with a safety database (e.g. ARGUS, ArisGlobal, etc.) required
- Knowledge of medical terminology required
- Knowledge of NovoNordisk supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)
- Experience with audits/inspections preferred
- Proficiency in Windows, Microsoft Word, Excel and Outlook required
- Experience Customer Service interaction preferred
- Analytical thinking skills
- Strong oral and written communication skills
- Ability to work with sensitive or confidential information
- Strong attention to detail
- Ability to handle multiple priorities and demands in a fast-paced environment
- Strong planning, organizational and time management skills
- Ability to interact with various levels of the organization
- Ability to form strong working relationships with stakeholders 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.
Associate Manager - Plainsboro, United States - Novo Nordisk
Description
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
Advanced level position expected to perform and aid with coordination of all daily operations within Patient Safety's Case Handling teams, which are responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including serious and non-serious adverse events, for Novo Nordisk Inc. (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 by providing guidance, training and mentorship to all team members.
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 and external vendors.
Essential FunctionsSupport contract and vendor management, and perform reconciliations for assigned vendors/business partners, as neededServe as Subject Matter Expert during audits/inspections on all Case Handling processes and take an active role in the audit/inspection process (e.g. perform document review, coach auditees, manage document requests, scribe)Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actionsBuild customer loyalty by providing high quality customer serviceIdentify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutionsLead department related projectsAbility to perform all responsibilities of more junior staff, including but not limited to:Processing of serious and non-serious 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:Data entry, duplicate searches, product coding, MedDRA coding, narrative generation, labeling assessment according to the current approved product labelSupport the evaluation of regulatory submission of expedited safety reports from the daily GSP listsParticipate in PRB meetings for all assigned NN products, as neededReceive inbound and make outbound calls for adverse events and technical complaints including handling of refunds and replacement requestsPerform data entry and review of non-serious 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 quality as per NN standardHandle incoming and outgoing follow-up correspondenceCollect and document information received during outbound follow-up callsPerform triage, case classification and case assignmentHandle escalated calls for all case typesAssist with training of new hires; mentor new hiresAssist with management of workload coordination/distributionPerform call monitoring as neededProvide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scriptsAssist with functions of overall management of the team in coordination with manager (e.g. participate in new candidate interviews, workload coordination, attending meetings and assisting with resulting actions which impact the team)
Physical Requirements
0-10% overnight travel required; May be required to work company holidays and weekends.
Qualifications