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Clinical Data Manager
1 week ago
A challenging opportunity has arisen within Eli Lilly for a Clinical Data Manager to join our Pharmacovigilance team. In this role, you will be responsible for the management of adverse event data within GPS systems, ensuring data integrity, consistency, and compliance with regulatory requirements.
About the Role
You will work closely with cross-functional teams to ensure that adverse events are processed and reported in a timely and accurate manner. This includes assessing individual reports, identifying gaps in information, and conducting follow-up to clarify seriousness, expectedness, causality, and achieving case completion. You will also be responsible for translating global, regional, and local PhV regulatory requirements into expedited reporting rules and conducting Product License studies activities.
Key Responsibilities
- Manage adverse events arising from various sources, including literature, Patient Support Programs, Clinical Trials, spontaneous reports, etc.
- Ensure the completeness and accuracy of data management within the GPS Systems and other associated case management activities.
- Complete or verify MedDRA coding, identify concomitant medication and relevant medical history, and ensure appropriate Follow Up is obtained utilizing a customer experience mindset.
- Prioritize work to ensure internal and regulatory timelines are met, proactively manage incoming work by collaborating with global colleagues, and provide expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements.
Requirements
- Master's degree or equivalent experience in a healthcare-related field or pharmaceutical/biological science preferred.
- 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, including word processing, tables, graphics, spreadsheets, presentations, templates, databases, search engines, etc.
- Fluency in English (write, read, speak).
Benefits
Eli Lilly offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
