Sr. Director - PV Case Management ICSR at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

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)
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
Strong working knowledge and understanding of regulations, guidelines, and regulatory precedence

Responsibilities

Provide technical leadership for the design, development, and implementation of Lilly’s end-to-end case management capabilities
Oversee ICSR activities and case quality, including data analysis, trend reporting, KPIs, and business insights
Represent Case Management on cross-functional teams
Accountable for optimization, digital enablement, and operational excellence across the product lifecycle to meet regulatory requirements and Lilly standards
Serve as the point of accountability for managing key ICSR vendor relationships
Lead 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
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
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

Skills

ICSR

Case Management

Pharmacovigilance

Data Analysis

Trend Reporting

KPIs

Regulatory Compliance

Vendor Management

Safety Systems

Digital Enablement

Operational Excellence

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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