The Position Oversee end-to-end case processing processes and resourcing. Lead Case Management Activities, including oversight of case Intake, Triage, and case processing. Oversee vendors and manage ICSR Verification teams to ensure efficient case processing and assessment. Serve as subject matter expert for case processing issues; provide support/escalation for internal teams and external stakeholders (patients and healthcare professionals) on inquiries, case handling issues, and patient-safety process improvements. Essential Functions Leadership & OversightLead and manage the global Case Processing team; foster accountability, collaboration, and continuous improvement. Provide expert guidance to cross-functional teams on safety case management activities. Process Development & OptimizationDesign, implement, and continuously improve AE/SAE case processing procedures (data collection, assignment, coding, narrative development, and case assessment). Ensure alignment with evolving regulatory requirements and industry best practices. Global CoordinationOversee communication and workflow integration across hubs (U.S., Mexico City, Bangalore) and external vendors/contractors. Ensure seamless operations and timely delivery of safety data. Risk ManagementPrimary escalation point for case-related risks and operational challenges. Collaborate to identify and mitigate potential issues. Compliance & Quality AssurancePartner with NNI Patient Safety Management to ensure timely/accurate safety information processing. Monitor workflows and performance metrics to meet KPIs and regulatory compliance. Audit & Inspection ReadinessSupport internal/external audits and regulatory inspections. Ensure documentation/processes are audit-ready and aligned with global pharmacovigilance standards. Physical Requirements 0–10% travel required. Supervisory / Development of People Ensure reporting personnel have IDPs with annual goals and interim reviews aligned to business priorities. Manage application and communication of policies, procedures, and Novo Nordisk Way. Qualifications Bachelor’s degree required; advanced degree preferred (M.S., Pharm. D., Ph.D., M.D.). 10+ years’ experience in scientific/regulatory/pharmaceutical/medical areas; 5–8 years in pharmacovigilance required. 5+ years supervisory management experience preferred. SME knowledge of global regulations (FDA, ICH). Expertise in safety databases, call center telephony systems, and quality systems. Preferred: knowledge of NNI-supported disease states (e.g., diabetes, obesity, hemophilia, growth hormone disorders). Required: strong communication and organizational skills. Expertise in workflow, budgeting, and KPI monitoring. Benefits Company bonus. Long-term incentive compensation and/or company vehicles (depending on position level). Medical, dental, and vision coverage; life and disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement; voluntary benefits; time off (sick time, flex-able vacation) and parental leave. #J-18808-Ljbffr