Senior Director – PV Case Management, ICSR
Eli Lilly and Company
full-time
Posted on:
Location Type: Hybrid
Location: Indianapolis • 🇺🇸 United States
Visit company websiteSalary
💰 $156,000 - $228,800 per year
Job Level
Senior
About the role
- The Sr. Director PV Case Management 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.
- This role 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.
- 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).
- Lead strategic optimization of ICSR intake operations across all channels including clinical trials, spontaneous reports, literature surveillance, digital platforms, and post-marketing sources to ensure efficient, accurate, and compliant case capture throughout the product lifecycle.
- Drive implementation of intake triage strategies, automation technologies, and standardized workflows to enhance case processing efficiency, reduce cycle times, and improve data quality at point of entry.
- Establish and monitor intake-related KPIs (e.g., acknowledgment timeliness, data completeness at intake, channel-specific volumes) to identify bottlenecks and drive continuous improvement in multi-channel case receipt processes.
- 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.
Requirements
- Bachelor's degree in nursing, pharmacy, life sciences, health care or related field; required
- Minimum of 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
- Experienced in regulatory inspections
- Proficiency with safety operation systems and tools (e.g., Safety database, MedDRA) preferred.
- Strong leadership, strategic thinking, and decision-making skills.
- Proven track record of successfully managing drug safety operations in a biotechnology or pharmaceutical company.
- Demonstrated strong written, spoken and presentation communication skills to all levels and areas.
- Demonstrated leadership, negotiation, influence skills, and authority without direct responsibility.
- Demonstrated experience and continuous improvement of processes mindset.
- Ability to travel for business (25 – 50%)
Benefits
- Eligibility to participate in a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysistrend reportingKPI establishmentadverse event reportingcase managementpharmacovigilance regulationsregulatory compliancedata analyticsprocess optimizationcontinuous improvement
Soft skills
leadershipstrategic thinkingdecision-makingcommunicationnegotiationinfluenceproblem-solvingcollaborationadaptabilityprocess mindset