Senior Patient Safety Case Management Manager

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
• Aid with preparation of periodic and annual reports for submission to the FDA
• 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
• 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)
• 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 Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions
• 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
• Prepare 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
• 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
• 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