Pharmacovigilance Specialist

Job Title: Safety & Pharmacovigilance Specialist II (ICSR)

Location: Gurugram / Hyderabad (Work from Office No Hybrid)

Shift: Regular Shift

Experience: 2-7 yrs

Role Overview

We are hiring experienced Safety & Pharmacovigilance Specialists I/ II with strong expertise in ICSR case processing. The role focuses on end-to-end case handling, with initial involvement in data entry and progression into quality review activities.

Key Responsibilities

• Perform end-to-end ICSR case processing (Spontaneous / Clinical Trial / Literature cases)
• Execute accurate data entry activities as part of core responsibilities (initial phase)
• Handle case workflows including triage, data entry, coding, narrative writing, and submission readiness
• Ensure compliance with global pharmacovigilance guidelines, SOPs, and regulatory requirements
• Perform quality checks (QC) on processed cases based on experience and performance
• Maintain high standards of accuracy, quality, and timelines in deliverables
• Collaborate with internal teams to ensure smooth case processing and reporting.

Required Skills & Experience

• 2.6-6.5years of relevant experience in ICSR case processing
• Hands-on experience with Argus / ArisG safety databases
• Strong understanding of pharmacovigilance processes and regulatory compliance
• Experience in data entry, case processing, and workflow management
• High attention to detail and quality orientation