Back to jobsAbility 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
