At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Purpose: The Sr. Director PV Case Management Individual Case Safety Reporting (ICSR) provides technical leadership for the design, development, and implementation of Lilly’s end-to-end case management capabilities. The role oversees ICSR activities and case quality, including data analysis, trend reporting, KPIs, and business insights, while representing Case Management on cross-functional teams. It is accountable for optimization, digital enablement, and operational excellence across the product lifecycle to meet regulatory requirements and Lilly standards and may also serve as the point of accountability for managing key ICSR vendor relationships.
In addition, the Sr. Director leads global projects involving complex safety systems, ensuring strategy and risks are considered, lessons learned are applied, and consistency and continuous improvement are driven across the organization. This is accomplished through a strong working knowledge and understanding of regulations, guidelines, and regulatory precedence.
1.Case Management Leadership
- Serve as a leading technical expert in Individual Case Safety Reporting (ICSR) and case management, providing high-quality, timely, and decisive advice to support sound business decisions and regulatory compliance.
- Deliver expert insight on best practices, emerging trends and partner with internal stakeholders and external partners, including vendors and license partners, to optimize the end-to-end collection, evaluation, and reporting of adverse events from all sources (clinical, spontaneous, literature, partners).
- Oversee ICSR CRO/vendor relationships, including process review, issue identification, and coordination of remediation and training as needed.
- Maintain deep expertise and adherence to international regulations (FDA, EMA, ICH) related to ICSR and reporting, applying this knowledge to identify, prevent, and solve challenging issues in case management.
- Provide technical and strategic leadership for complex projects aimed at advancing case management tools, systems, ICSR standards and methodologies, including the integration of new technologies to enhance case management efficiency and drive innovation.
- Define, implement, and monitor a comprehensive set of global ICSR metrics (e.g., submission timeliness, quality, completeness) to measure compliance, effectiveness and efficiency, leveraging data analytics to inform decisions and enhance case management performance and identify areas for optimization.
- Establish and monitor safety business insights via data analyses and dashboards to support leadership visibility and decision making related to case management to proactively identify bottlenecks, emerging risks, and opportunities for improvement.
- Conduct regular reviews of case management activities, monitor regulatory developments and proactively adjust case management processes to ensure compliance with internal and external standards.
- Establish and monitor key performance indicators (KPIs) for case processing vendors
- Champion continuous improvement across case management by leading root cause investigations, implementing corrective and preventive actions, and monitoring their impact.
- Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs).
- Act as the expert for regulatory inspections and internal/external audits by ensuring case management practices meet global compliance standards; lead preparation activities, provide subject matter expertise, and drive timely resolution of findings related to ICSR processes.
- Build, mentor and maintain a strong community of ICSR subject matter experts (SMEs), fostering a culture of accountability, collaboration, knowledge sharing, and capability building across case management.
- Perform other tasks as assigned by the AVP Case Management.
MINIMUM QUALIFICATION REQUIREMENTS:
- Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field; required
- 8+ years of experience in the biotech or pharmaceutical industry
- 5+ years in ICSR, Case Management, PV Operations, or equivalent.
- Extensive knowledge of pharmacovigilance regulations and guidelines, e.g. FDA, EMA, ICH, and other global regulations and guidelines
- Expertise in adverse event reporting, vendor and performance management.
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