Director - Patient Safety - Case Management

Role Summary

Director - Patient Safety - Case Management. Responsible for overseeing end-to-end processes and resourcing for case processing, leading Case Management Activities, and oversight of Intake, Triage, case processing, Vendors, and ICSR Verification teams. Acts as an expert on case processing issues and provides support and escalation channels for internal teams and external stakeholders related to patient safety.

Responsibilities

• Leadership & Oversight: Lead and manage the global Case Processing team, fostering 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 procedures for AE/SAE case processing, data collection, assignment, coding, narrative development, and case assessment; ensure alignment with regulatory requirements and industry best practices.
• Global Coordination: Oversee communication and workflow integration across case processing hubs and external vendors/contractors; ensure seamless operations and timely delivery of safety data.
• Risk Management: Primary point of escalation for case-related risks and operational challenges; collaborate with internal stakeholders to identify and mitigate issues.
• Compliance & Quality Assurance: Partner with NNI Patient Safety Management to ensure timely and accurate processing of safety information per corporate standards; monitor workflows and metrics to meet KPIs and regulatory compliance.
• Audit & Inspection Readiness: Support preparation and execution of internal and external audits and regulatory inspections; ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards.

Qualifications

• A bachelor‚Äôs degree required; advanced degree preferred (M.S., Pharm. D., Ph.D., M.D.).
• At least 10 years of experience in Scientific, Regulatory, Pharmaceutical, and Medical areas, with 5‚Äì8 years in pharmacovigilance.
• Supervisory management experience of at least five years preferred.
• Subject matter expertise in global regulations including FDA and ICH guidelines.
• Expertise in safety databases, call center telephony systems, and quality systems.
• Knowledge of NNI-supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders).
• Good communication and organizational skills; expertise in workflow, budgeting, and KPI monitoring.

Skills

• Safety case management
• Regulatory compliance
• Process design and optimization
• Vendor and contract management
• Data analysis and KPI monitoring
• Audit and inspection readiness

Education

• Bachelor‚Äôs degree required; advanced degree preferred

Additional Requirements

• 0-10% travel required