Director, Patient Safety Case Management

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 & Oversight
- Lead 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 & Optimization
- Design, 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 Coordination
- Oversee 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 Management
- Primary escalation point for case-related risks and operational challenges.
- Collaborate to identify and mitigate potential issues.
- Compliance & Quality Assurance
- Partner 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 Readiness
- Support 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.

Application Instructions
- If you need special assistance/accommodation to apply: call 1-855-411-5290 (accommodation requests only).