08 Aug
|
Syneos Health
|
Hyderabad
08 Aug
Syneos Health
Hyderabad
Job Title: Safety & Pharmacovigilance Specialist II (ICSR)
Location: Gurugram / Hyderabad (Work from Office No Hybrid)
Shift: Regular Shift
Experience: 2.6-6.5 Years
Role Overview
We are hiring experienced Safety & Pharmacovigilance Specialists I/ II with robust 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
📌 Pharmacovigilance Specialist (Hyderabad)
🏢 Syneos Health
📍 Hyderabad