Sr Director, Global Patient Safety - Medical Review at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Direct technical and administrative leadership experience for a global team of therapeutically aligned Medical Review physicians and scientists
Ability to work in close collaboration with and report to the Senior Director/Executive Director – GPS Medical Review
Capability to collaborate with leaders globally responsible for Medical Review and Case Management
Deep regulatory and technical expertise in the therapeutic area
Medical knowledge and expertise in the therapeutic area portfolio

Responsibilities

Supervise Medical Review personnel within the therapeutic area across the global team, including physicians and scientists
Build deep regulatory and technical expertise through recruitment, development, and retention of staff
Facilitate, train, and mentor Medical Reviewers in the responsibilities of the role
Provide feedback and coaching, support short- and long-term development plans, and ensure appropriate individual recognition
Oversee the medical evaluation of safety of Individual Case Safety Reports for all assigned compounds across their life cycle to inform the safety profile of the therapeutic area portfolio
Develop, maintain, and share technical expertise and medical knowledge in the therapeutic area
Provide strong global medical leadership that influences scientific and process improvements and drives change within the organization
Lead and participate in process improvement and innovation projects to support the safety of all assigned compounds
Participate in the development and implementation of the functional strategic plan for Medical Review
Manage resources to meet business objectives and future needs within the therapeutic area in collaboration with leaders across the global team
Collaborate cross-functionally to ensure alignment of goals and deliverables, readjusting as business needs dictate
Partner closely with global GPS partners for efficient resource forecasting, planning, and utilization

Skills

Patient Safety

Medical Review

Pharmacovigilance

Healthcare Compliance

Clinical Risk Management

Regulatory Affairs

Adverse Event Reporting

Global Safety Governance

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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