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
To ensure compliance with all Federal regulations and company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI) US marketed products (drugs and devices). To support workflow management and coordination of all daily operations of Product patient Safety's case processing activities, which include the receipt, documentation, triage, case review, and quality assessment of all inbound safety information, including serious and non-serious adverse events, for NNI US marketed products (drugs and devices). To contribute and support activities related to compliance reporting and quality tasks in order to ensure consistency and compliance in all activities performed by Patient Safety.
Relationships
Reports to Patient Safety Director. Works closely with, including not limited to the following: all units in Patient Safety, Global Safety, Medical Information, Field Sales, Customer Complaints Center, GXP Support, Legal, Compliance, Commercial, Finance and Patient Centric Customer Care. External relationships include interactions with patients, caregivers, healthcare professionals, FDA, NNI business partners, and vendors.
Essential Functions
- Ability to perform all responsibilities of more junior case processing staff; perform any or all of these activities when needed to support the team, 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
- Contribute and support the evaluation of daily GXP lists for regulatory submission of individual case safety reports from both post-marketing and clinical trial sources to the FDA
- Assist with preparation of periodic and annual reports for submission to the FDA
- Monitor the quality of Product patient Safety deliverables and provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure case quality as per NN standard
- Support triage, case classification and case assignment, handle workflow case allocation, or assist with management of workload coordination/distribution when needed
- Handle escalated calls for all case types and investigate solutions for unique situations by collaborating across the Organization
- Support Patient Safety’s responsibilities and maintain oversight toward Patient Support Programs, Market Research Programs, call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, and supplier relations
- In collaboration with Patient Safety training specialist and people managers, support internal and external training activities such as safety reporting training for all employees in NNI, or external stakeholders
- Serve as Subject Matter Expert during audits/inspections on all case processing and compliance reporting processes and take lead role in the audit/inspection process (e.g., prepare pre-audit requests, perform document review, coach auditees, manage document requests, front room auditee, messenger, 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 actions
- Ensure timely registration of deviation(s) and participate, as needed, in defining and driving the implementation of correction, corrective and preventive actions in response to quality and/or compliance issues
- Collaborate with other units within Patient Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management. Directs employees on proper root cause analysis, identification, documentation, correction, and corrective action, as appropriate
- Responsible for the preparation of monthly internal KPI monitoring report and Time Limit Exceeding updates for Head of Patient Safety. Reports/updates require analysis of late cases that occur during the month, prepare root cause analyses, review the data for trends, and make recommendations for process changes and other corrective actions to prevent future late reporting and ensure FDA reporting compliance
- Support the collection, analysis, tracking, monitoring, and reporting of case processing workflow metrics including Case Handling Key Performance Indicator (KPI) data received from Global Safety to Patient Safety Management
- Responsible for timely review and preparation of Quality Management Review (QMR) reporting content for Patient Safety and Global Safety
- Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts and investigate new responses for unique situations
- Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutions either independently or by leading a team
- Lead department related projects including system upgrades, boosters, and system improvement initiatives
- Develop and maintain local (safety) SOPs. Collaborate with Global Safety on global SOP updates and regulatory changes
Physical Requirements
0-10% overnight travel required; may be required to work company holidays and weekends. This position is located in Plainsboro, NJ and required to work onsite 5 days per week.
Qualifications
- A minimum of 8 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event reporting) required
- A bachelor’s degree required (in medical or life science-related discipline); relevant experience may be substituted for degree, when appropriate (e.g., Registered Nurse with a minimum of 5 years of experience, including 3 years in clinical setting providing patient care and/or safety reporting). Advanced degree preferred
- Experience with a pharmacovigilance database (e.g., ARGUS, ArisGlobal) required
- Exceptional knowledge of medical and pharmacovigilance 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 or a minimum of 2 years of Customer Service experience 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
The base compensation range for this position is $[ ] to $[ ]. 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.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
