Lilly Pharmaceutical Sciences Associate Job Opening – Apply Online
Associate/Senior Associate – Safety Management
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
At Lilly, we combine caring with discovery to enhance lives globally. As a healthcare leader headquartered in Indianapolis, Indiana, our mission is to bring life-changing medicines to those in need, improve disease management, and support communities through philanthropy and volunteerism. We strive for excellence in our work and prioritize people. We seek individuals committed to making life better for people worldwide.
Primary Responsibilities
- Apply clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems, ensuring data integrity, consistency, and compliance.
- Expand knowledge continuously on Lilly compounds/products, including clinical trial design, safety profiles, regulatory commitments, indications, identified risks, main adverse reactions, and risk minimization activities.
- Increase regulatory expertise on case collection and expedited reporting requirements of major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
- Participate as a cross-functional team member on study teams as assigned.
- Understand and contribute to the functioning of GPS-owned systems (e.g., MOSAIC, LSS), including updates, enhancements, and workflow solutions.
- Process adverse events and other safety information from multiple sources (e.g., Clinical Trials, Patient Support Programs, Lilly Market Research, literature, spontaneous reports).
- Assess individual reports, identify information gaps, conduct follow-up to 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 system issue/enhancement initiatives.
- Translate global/regional/local PhV regulatory requirements into expedited reporting rules and manage Product License study activities.
- 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.
Minimum Qualification Requirements:
- Master’s degree or equivalent experience. Healthcare degree, or study in the area of 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 (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines).
- Ability to work effectively in a global team and apply understanding of diversity and inclusion.
- Fluency in English (write / read / speak)
Apply for this position at: Associate/Senior Associate – Safety Management
Keywords: Associate, Senior Associate, Safety Management, Bangalore, Karnataka, India, Research & Development, Full Time, Lilly, Healthcare. Lilly Pharmaceutical Sciences Associate Job Opening – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.