Safety Management at Eli Lilly and Company

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Master’s degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science preferred
A minimum of 4 years and up to 8 years of relevant professional experience
Critical thinking to solve problems, and make decisions autonomously, and as part of a team
Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems
Basic computer skills (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines)
Ability to work effectively in a global team and apply understanding

Responsibilities

Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure 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)
Participate as a cross functional team member of study teams, as assigned
Understand functioning of systems owned GPS (e.g., MOSAIC, LSS), contributing with updates / enhancements and solution of workflow issues
Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, Lilly Market Research, literature, spontaneous reports, etc.)
Assess individual reports identifying gaps of information and the need to conduct follow-up to clarify seriousness, expectedness, causality and achieve case completion
Comply with internal and external timelines for managing adverse event data entry
Lead/support literature search strategy updates and system issues/enhancements
Translate global / regional / local PhV regulatory requirements into expedited reporting rules and conduct Product License studies activities
Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities, including management of adverse events from various sources (e.g., literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous, pregnancy, devices, Lilly Market Research (LMR), etc.)
Ensure appropriate serious outcome criteria for adverse events are selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review
Complete or verify MedDRA coding
Identify concomitant medication and relevant medical history
Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel
Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues
Prioritize work to ensure internal and regulatory timelines are met
Be a pro-active member providing expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements
Maintain understanding of PV agreements for assigned products

Skills

adverse event management

GPS systems

MOSAIC

LSS

clinical judgement

critical thinking

regulatory knowledge

FDA

EMA

MHRA

PMDA

pharmacovigilance

case processing

literature search

expedited reporting

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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