Global Drug Product Safety - Analyst

Roles & Responsibilities:
• Perform data entry of adverse event reports into the pharmacovigilance (PV) database
• Assess seriousness and causality of adverse event cases as per regulatory guidelines
• Validate data against source documents and call notes for accuracy
• Ensure completeness, correctness, and quality of cases prior to regulatory submission
• Identify potential delays in case processing and escalate issues appropriately
• Determine need for follow-up information and ensure timely case closure
• Comply with internal and global timelines for adverse event and product complaint processing
• Maintain adherence to global and local pharmacovigilance regulations
• Meet expected productivity and quality benchmarks
• Actively participate in team meetings and support assigned PV activities

Qualification:
• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience OR
• Bachelor’s degree in Life Sciences with 0–2 years of pharmacovigilance experience
• Bachelor of Pharmacy, Master of Pharmacy, Docotor of Pharmacy

Experience:
• 0–2 years of experience in pharmacovigilance / adverse event case processing preferred

Skills:
• Basic knowledge of medical terminology relevant to pharmacovigilance
• Understanding of global and local regulatory requirements
• Strong attention to detail and data accuracy
• Effective written and verbal communication skills
• Ability to manage multiple products and priorities simultaneously
• Proficiency in working with multiple databases
• Flexibility to manage high-volume case processing
• Self-motivated and adaptable to dynamic environments

About the Organization:
Elanco is a global leader in animal health dedicated to innovation in preventing and treating diseases in farm animals and pets, fostering a diverse and inclusive culture focused on improving animal health worldwide.