Safety Data Management Specialist – Global Pharmacovigilance | Eli Lilly
Location: Indianapolis, Indiana (Global Operations)
Company: Eli Lilly
Experience Required: As described in the job role (minimum 4–8 years of relevant professional experience)
About Eli Lilly
Eli Lilly is a global healthcare leader committed to uniting scientific discovery with a deep sense of care to improve lives worldwide. Headquartered in Indianapolis, Indiana, Lilly delivers life-changing medicines, advances the understanding and management of disease, and invests in communities through philanthropy and volunteer initiatives. The company fosters a people-first culture and empowers employees to drive meaningful impact across global health.
Position Overview
The Safety Data Management Specialist plays a key role within Lilly’s Global Patient Safety (GPS) organization. This position is responsible for ensuring the accuracy, integrity, and regulatory compliance of adverse event data across GPS systems. The role requires strong clinical judgment, critical thinking, and an in-depth understanding of pharmacovigilance regulations and safety reporting standards.
This opportunity is ideal for experienced professionals seeking to contribute to global safety operations, collaborate across functions, and support continuous enhancement of safety systems.
Key Responsibilities
Apply clinical expertise, regulatory knowledge, and analytical skills to maintain quality, consistency, and compliance of adverse event data within GPS systems.
Expand working knowledge of Lilly products, clinical trial design, safety profiles, regulatory commitments, indications, risk minimization strategies, and known adverse reactions.
Stay current with global pharmacovigilance requirements, including expedited reporting expectations from agencies such as FDA, EMA, MHRA, and PMDA.
Participate as a cross-functional member of assigned study teams, contributing safety insights and operational expertise.
Support the functionality and improvement of GPS-owned systems (e.g., MOSAIC, LSS), including workflow troubleshooting and enhancement recommendations.
Process adverse events and safety information from multiple sources including clinical trials, patient support programs, market research, spontaneous reports, literature, and more.
Evaluate incoming safety reports to identify missing details, assess seriousness and expectedness, determine causality, and coordinate follow-up for case completion.
Ensure compliance with internal and regulatory timelines for adverse event data entry and reporting.
Lead or support literature search strategy updates and system enhancements.
Translate global, regional, and local pharmacovigilance requirements into clear expedited reporting rules and support Product License study activities.
Manage the complete lifecycle of adverse event data across sources such as literature, PSPs, clinical trials, spontaneous reports, pregnancy cases, medical devices, and market research.
Perform or verify MedDRA coding and ensure accurate selection of seriousness criteria, expectedness, relatedness, and case details for medical review.
Identify and document relevant medical history and concomitant medications.
Conduct follow-up with patients, healthcare professionals, or investigator sites with a strong customer-focused approach.
Collaborate with global colleagues to prioritize workload and proactively manage incoming case volume.
Support local and global initiatives aimed at driving innovation and continuous improvement in safety management processes.
Maintain detailed knowledge of pharmacovigilance agreements for assigned products.
Minimum Qualifications
Master’s degree or equivalent experience (healthcare, pharmaceutical, or biological sciences preferred).
A minimum of 4 to 8 years of relevant professional experience as outlined in the job role.
Strong critical thinking skills and the ability to independently resolve issues and make sound decisions.
Adaptability in using electronic systems and willingness to learn new and evolving technologies.
Proficiency in standard software tools including word processing, spreadsheets, presentations, databases, and online search resources.
Ability to operate effectively within global teams, with a strong commitment to diversity and inclusion.
Fluency in English (reading, writing, and speaking).
Accessibility and Equal Opportunity
Eli Lilly is committed to creating an inclusive environment and providing equal employment opportunities. Individuals requiring accommodations during the application process may submit a request through the company’s accommodation portal. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, or any other legally protected characteristic.
For more global pharmacovigilance and life-science career opportunities, visit ThePharmaDaily.com.
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