Join Lilly as an Associate, Senior Associate in Safety Management!
Location: Bangalore, Karnataka, India
At Lilly, we are dedicated to improving lives worldwide through our innovative healthcare solutions. As a global leader in healthcare headquartered in Indianapolis, Indiana, we focus on discovering life-changing medicines, enhancing disease management, and contributing to communities through philanthropy and volunteerism. We prioritize people and are committed to making a positive impact on a global scale.
Primary Responsibilities:
- Utilize clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems, ensuring data integrity, consistency, and compliance.
- Expand knowledge of Lilly compounds/products, including clinical trial design, safety profiles, regulatory commitments, indications, risks, adverse reactions, and risk minimization activities.
- Enhance regulatory expertise on case collection and expedited reporting requirements per major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
- Participate as a cross-functional team member in study teams as assigned.
- Understand and contribute to the enhancement of GPS systems (e.g., MOSAIC, LSS), resolving workflow issues and implementing updates.
- Process adverse events and safety information from various sources (e.g., Clinical Trials, Patient Support Programs, literature, spontaneous reports).
- Assess individual reports, conduct follow-ups, clarify seriousness, expectedness, causality, and achieve case completion.
- Comply with internal and external timelines for adverse event data entry.
- Lead/support literature search strategy updates and address system issues/enhancements.
- Translate global/regional/local Pharmacovigilance (PhV) regulatory requirements into expedited reporting rules and conduct Product License studies activities.
- Ensure completeness and accuracy of data management within GPS Systems and associated case management activities.
- Maintain understanding of PV agreements for assigned products.
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Eli Lilly and Company Hiring Associate, Senior Associate in Safety Management[/caption]
Minimum Qualification Requirements:
- Master’s degree or equivalent experience in a healthcare/pharmaceutical/biological science field.
- Strong critical thinking, problem-solving skills, and ability to make autonomous decisions.
- Proficiency in using electronic systems, adapting to new technologies, and working effectively in a global team.
- Basic computer skills (word processing, spreadsheets, presentations).
- Fluency in English (reading, writing, speaking).
Join us at Lilly and be part of a dynamic team committed to innovation, diversity, and improving public health through Safety Management. To apply, please submit your resume to Lilly Human Resources at
Lilly_Recruiting_Compliance@lists.lilly.com. For accommodations during the application process, please email us at the provided address.
At Lilly, we value diversity, inclusion, and equal opportunity for all candidates. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
https://pharmastuff.org.in/job/lilly-associate-senior-associate-safety-management
