Sr. Director - PV Case Management ICSR

Chester, Maryland, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

The Sr. Director requires technical leadership experience in Individual Case Safety Reporting (ICSR) and case management. A deep understanding of international regulations (FDA, EMA, ICH) related to ICSR and reporting is essential. Experience in leading global projects involving complex safety systems and managing vendor relationships is also necessary. The role demands expertise in data analysis, trend reporting, and key performance indicators (KPIs).

Responsibilities

The Sr. Director will provide technical leadership for the design, development, and implementation of Lilly’s end-to-end case management capabilities. This includes overseeing ICSR activities and case quality, representing Case Management on cross-functional teams, and optimizing digital enablement and operational excellence. Responsibilities also encompass leading global projects for advancing case management tools and systems, defining and monitoring global ICSR metrics, establishing safety business insights through data analysis, and ensuring compliance with internal and external standards. The role involves championing continuous improvement, leading root cause investigations, and implementing corrective actions, as well as managing key ICSR vendor relationships.

Skills

PV Case Management

ICSR

Regulatory Compliance

Data Analysis

Trend Reporting

KPIs

Business Insights

Vendor Management

Global Projects

Safety Systems

Risk Management

Continuous Improvement

Pharmacovigilance

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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