Clinical Surveillance Scientist at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Clinical and scientific expertise to lead detection of safety signals, evaluation of safety data, and assessment of safety risks
Effective prioritization, critical thinking, and judgment-based decision making to execute deliverables in compliance with global regulations and internal processes
Effective communication and influence skills with internal and external stakeholders
Ability to understand and communicate scientific issues and strategy
Experience in pharmacovigilance, including signal detection, data analysis, and regulatory reporting

Responsibilities

Drive identification, analysis, and evaluation of safety signals from multiple internal and external data sources, determining signals or risks impacting labels or benefit-risk profile; collaborate with safety personnel
Develop and review label changes and labelling modifications in collaboration with teams, regulatory, and legal
Lead and facilitate safety team meetings for compounds in clinical development and marketed products using effective communication skills
Define data acquisition strategy, methodology, and approach for safety evaluations; perform analysis of safety data and lead authoring of safety topic reports
Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and others for thorough evaluation and aggregate analysis of safety data
Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
Lead analysis of safety data and author safety sections of global regulatory inquiries and periodic reports (DSURs, PADER/PAER, PSURs, PBRERs, RMPs)
Provide input to safety communications including labeling, medical information inquiries, and HCP letters
Communicate and influence effectively with internal Lilly customers (medical, regulatory, labeling) and external stakeholders (FDA, MHRA, EMA, etc.)
Accelerate advancement of pharmacovigilance field and contribute to development/coaching of peers and less experienced employees
Identify and develop innovative approaches to improve organizational effectiveness and productivity
Function and communicate effectively in inclusive cross-functional teams fostering trust, respect, and accountability

Skills

Pharmacovigilance

Signal Detection

Safety Data Evaluation

Risk Assessment

Regulatory Reporting

Label Changes

Benefit-Risk Assessment

Critical Thinking

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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