Safety Management

Role & Responsibilities
• Manage and review adverse event data ensuring accuracy, consistency, and regulatory compliance
• Apply clinical judgment and regulatory knowledge to safety case processing
• Process safety reports from clinical trials, spontaneous reports, literature, PSPs, and market research
• Perform MedDRA coding, seriousness, causality, and listedness assessments
• Identify data gaps and conduct follow-ups with investigators, HCPs, and patients
• Ensure compliance with global expedited reporting requirements including FDA, EMA, MHRA, and PMDA
• Work with global safety systems such as MOSAIC and LSS
• Collaborate with cross-functional and global pharmacovigilance teams
• Support literature search strategies and safety workflow improvements
• Maintain awareness of pharmacovigilance agreements and regulatory commitments

Qualification
• Master’s Degree in Pharmacy, Life Sciences, Biological Sciences, or Healthcare

Experience
• 4–8 years of experience in Pharmacovigilance or Drug Safety
• Hands-on experience in adverse event management and regulatory reporting
• Exposure to global safety operations and electronic PV systems

Skills
• Strong understanding of global pharmacovigilance regulations
• Excellent critical thinking and problem-solving abilities
• Proficiency in safety databases and case processing systems
• Strong written and verbal communication skills in English
• Ability to work effectively in global, cross-cultural teams

About the Company
• Eli Lilly and Company is a leading global pharmaceutical organization, Known for life-changing innovations and patient-centric healthcare solutions, Operates extensive global drug safety and regulatory programs.