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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 healthcare 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

The Manager PS Case Management is responsible for the management of receipt, documentation, triage and case processing safety information and associated quality complaints (PQC) for US Operations (USO) post-marketed products. This role processes cases based on timelines, compliance and regulatory requirements. This roles also serves as the subject matter expert in providing guidance, oversight and project management of assigned projects in Patient Safety.

Relationship

Reports directly to the Director, Patient Safety Case Management. This role involves the case handling and oversight of activities across the locations. Collaborate with the other departments within Patient Safety organization, CMR, outside of CMR, and Global Patient Safety and Safety Surveillance teams. Works closely with Promotional Review Board as required.

Essential Functions

+ Perform initial evaluation of reported adverse events from all sources

+ Perform case entry of adverse events (AEs) and associated product quality complaints (PQCs) and analysis results related to post-marketed products into patient safety systems ensuring completeness and accuracy

+ Review auto-generated narrative for non-serious cases and perform narrative writing for serious cases in patient safety systems

+ Perform accurate and consistent coding of medical terms (MedDRA) and products

+ Determine listedness of adverse events based on available information, evaluate medical confirmation, and ensure appropriate documentation

+ Perform case follow-up activities

+ Participate in inspection readiness and support audits/inspection as required

+ Ensure compliance with role-specific training plans and applicable reference documents

+ Participate in department meetings, internally and globally, as applicable

+ Support mentoring new hires and cross training on case processing associated activities

+ Participating in Patient Safety team projects as required

+ Oversee vendor case processing teams as required

+ Provide regular feedback to case processors on data entry quality and accuracy by using applicable verification feedback form

+ Assign safety cases received from various sources to all the hubs and vendors according to the Internal and regulatory timelines

+ Perform daily compliance checks to ensure adverse events, product quality complaints, and case-related tasks are prioritized and handled accordingly

Physical Requirements

0-10% travel required. Verbiage below applies only to Supervisory roles; it is removed for individual contributors - DO NOT EDIT. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

+ A bachelor’s degree required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate

+ A minimum of 5 years of experience within the pharmaceutical or healthcare industry. A minimum of 2 year’s of pharmacovigilance case processing experience is preferred

+ Experience in patient safety or pharmacovigilance preferred

+ Knowledge of medical terminology required

+ Knowledge of NovoNordisk supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)

+ Analytical thinking skills preferred

+ Experience with Drug Safety database preferred

+ Experience with MedDRA coding, narrative generation, evaluation of expectedness / listedness, and understanding of product labeling is preferred

+ Strong oral and written communication skills preferred

+ Strong planning, organizational and time management skills preferred

+ Ability to handle multiple priorities and demands in a fast-paced environment required

+ Ability to interact with various levels of the organization required

+ Ability to form strong working relationships with stakeholders required

+ Ability to work with sensitive or confidential information

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

The base compensation range for this position is $96,670 to 178,840. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.