Manager - Safety Management at Eli Lilly and Company

Cork, County Cork, Ireland

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Clinical judgement, critical thinking, and regulatory knowledge for managing adverse event data in GPS systems
Knowledge of Lilly compounds/products (e.g., clinical trials design, safety profile, regulatory commitments, indications, risks, adverse reactions, risk minimization)
Regulatory expertise on case collection and expedited reporting requirements (e.g., FDA, EMA, MHRA, PMDA)

Responsibilities

Apply clinical judgement, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems for data integrity, consistency, and compliance
Continuously expand knowledge of Lilly compounds/products (e.g., design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities)
Continuously expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA)
Partner with other GPS areas and clinical functions (e.g., authoring of ERB or Investigator line listing, contributing to maintenance of EPM and late phase clinical trials information, performing trial closure activities)
Prepare serious adverse event forms for clinical trials and provide testing assistance for Inform studies
Provide expertise related to data collection activities and configuration, ensuring data integrity through the data flow (e.g., Mosaic PV, Inform)
Provide device expertise, including resolving issues related to CATool use to ensure appropriate linking of adverse event/product complaint information, and complete follow-up/PC action items to update relevant product information timely
Provide support for translation processes
Provide shared learnings/training related to areas of proficiency
Participate as a cross-functional team member of study teams

Skills

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.

Land your dream remote job 3x faster with AI

Try Jobo Free