Sr. Director - PV Case Management ICSR

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.

2. Enterprise Leadership

• Represent Case Management at internal and external meetings, using insights from health authority discussions and industry events to help shape safety strategies across different forums.
• Stay involved with external and industry groups to benchmark and track changes in regulations and help shape policies related to Case Management and Individual Case Safety Reports (ICSRs).
• Partner cross-functionally to drive continuous improvement in workflows, leveraging performance metrics, root cause analysis, and automation strategies to enhance efficiency, accuracy, and scalability to support Lilly product safety and reduce risks.
• Collaborate with safety systems, data science, and IT teams to define and prioritize enhancements to case management tools and platforms.
• Work closely with teams across Lilly to support consistent global business processes.
• Build strong relationships with external vendors, CROs, and license partners to ensure alignment and oversight of outsourced case processing activities.
• Collaborate with procurement and quality functions to assess and manage vendor risks, contract changes, and audit findings.
• Demonstrate strong technical and leadership skills and actively support the growth of others through coaching and mentoring tailored to their needs and learning styles.

3. People Leadership 

• Recruit, develop, and retain scientific and operationally capable team members skilled and knowledgeable in pharmacovigilance and ICSR Case Management including intake, processing, reporting. 
• Effectively upskill and manage an agile case management team that continuously meets the needs of a changing portfolio. 
• Build a culture that fosters inclusion and innovation. 
• Develop staff who demonstrate expertise in end-to-end drug development and pharmacovigilance with an emphasis on case management
• Partner closely with other Global Patient Safety, Regulatory, Development and other functions to effectively plan, forecast, and manage the resources required to deliver enterprise priorities. 
   

4.Understand and Support of the EU QPPV role  

• Understanding the roles and responsibilities of the EU Qualified Person.  
• Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities. 

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. 

Other Information/Additional Preferences:

• 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 (15 – 25%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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