Director - Patient Safety - Case Management

Role Summary

Director - Patient Safety - Case Management. Responsible for overseeing the end-to-end processes and resourcing for case processing, including intake, triage, case processing, vendor oversight, and ICSR verification teams. Serves 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 regarding safety case management activities
• Process Development & Optimization
  • Design, implement, and continuously improve procedures for AE/SAE case processing, including data collection, assignment, coding (drug/event), narrative development, and case assessment
  • Ensure alignment with evolving 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
  • Act as the primary point of escalation for case-related risks and operational challenges
  • Collaborate with internal stakeholders to proactively identify and mitigate potential issues
• Compliance & Quality Assurance
  • Partner with NNI Patient Safety Management to ensure timely and accurate processing of safety information in accordance with corporate standards
  • Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met
• Audit & Inspection Readiness
  • Support the 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. An advanced degree is preferred (M.S., Pharm. D., Ph.D., M.D.)
• At least 10 years of experience related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least 5-8 years in pharmacovigilance
• Supervisory management experience of five years or more is preferred
• Subject matter expert knowledge of global regulations including FDA and ICH regulations/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)
• Strong communication and organizational skills
• Experience with Workflow, Budgeting and KPI monitoring

Skills

• Leadership and people management
• Global coordination and cross-functional collaboration
• Process design, optimization, and regulatory alignment
• Risk assessment and issue escalation
• Quality assurance and audit readiness

Additional Requirements

• Physical requirements: 0-10% travel may be required