Manager - Patient Safety - Team Lead

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 all daily operations of Patient Safety's Case processing Team, which is responsible for the receipt, documentation, triage, case review and quality assessment of all inbound safety information, including serious and non-serious adverse events and technical complaints, for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices) Provide day to day management of the Case Processing team and 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 Director, Patient Safety Case Management. Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Supply Chain, Customer Complaints Center, Patient Centric Customer Care and Global safety. Daily external interactions with patients, caregivers, health-care professionals and external vendors.

Essential Functions

• Ability to perform all responsibilities of more junior case processing 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 tool, complaint and global safety databases
  • Handle escalation calls from HCPs and consumers
  • Perform triage, case classification and case assignment, and handle workflow case allocation and oversight
  • Assist with training of new hires within PS and suppliers as needed. Support mentorship activities for case processing
  • Oversight of call monitoring
  • Serve as Subject Matter Expert during audits/inspections on all Case Handling processes and take an active role in the audit/inspection process
  • Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions
  • Serve as Case Handling Team’s Argus Workflow Manager
  • Review and collect Case handling metrics and provide analysis and presentation
  • Provide and conduct analysis and processing of Case Handling Key Performance Indicator (KPI) data received from Global Safety
  • Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutions
• Lead departmental related projects
  • Provide overall management of the team in coordination with PS Management Team (e.g. participate in new candidate interviews, workload coordination, attending meetings and assisting with resulting actions which impact the team)
  • Serve as member of the Patient Safety Management team

Physical Requirements

0-10% overnight travel required.

Development Of People

Supervisory. 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

• Bachelors degree required (in medical or science-related discipline) or  relevant experience may be substituted for degree, when appropriate
• A minimum of 8 years of progressively responsible, relevant experience, with at least 4 years in pharmacovigilance
• Customer service experience preferred
• Direct Report management experience preferred. A minimum of 3 years’ experience in peer-to-peer coaching/mentoring is 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 required
• 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

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