Pharmacovigilance Specialist

Job description

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