Sr Associate/Principal Associate, IT Systems Business Quality Assurance - Pharmacovigilance at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Experience in quality assurance, particularly in IT systems for pharmacovigilance or safety
Knowledge of Safety and Efficacy Quality System (SEQS) and related global policies
Ability to review and provide feedback on regional/local SOPs versus global policies
Skills in recommending new procedures or changes to existing ones
Capability to provide quality oversight for compliance
Experience escalating compliance issues to local and global management
Preparedness for inspection readiness and ensuring compliance with global, regional, and local regulations

Responsibilities

Ensure local implementation of the Safety and Efficacy Quality System (SEQS), including reviewing regional/local SOPs against global policies, providing feedback on quality system documents, recommending new or changed procedures, providing quality oversight, and escalating compliance issues
Ensure inspection readiness and compliance with global, regional, and/or local requirements for safety IT systems
Support development and implementation of quality systems strategy and activities for Global Patient Safety (GPS) goals and objectives in safety IT systems
Act as a quality consultant and leader in integrating quality requirements into business processes
Implement the quality plan and ensure consistency between global and local requirements
Implement safety quality systems and assure alignment with appropriate quality and regulatory requirements
Serve as the contact person for quality and business process compliance concerns with GPS IT systems

Skills

Quality Assurance

Pharmacovigilance

IT Systems

Business Analysis

Safety Surveillance

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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