Safety & PV Specialist (SS I) - Night Shift (Gurugram)
Core
Process and track Individual Case Safety Reports (ICSRs) for clinical trials and post-marketing programs, ensuring data accuracy and regulatory compliance.
Role type
Safety & Pharmacovigilance Specialist (IC)
Builds
Safety databases, regulatory reports, and Trial Master Files (TMF) for biopharmaceutical clients.
Domain
Biopharmaceuticals / Clinical Research / Pharmacovigilance
Required skills
ICSR case processing, Quality Check (QC), MedDRA coding, literature screening, regulatory reporting, TMF management, duplicate ICSR identification
Preferred skills
Experience with SPOR/IDMP activities, xEVMPD product record validation
Technologies
PVG quality and tracking systems, safety databases, MedDRA, xEVMPD
Responsibilities
Enter and track ICSRs in quality systems; triage and evaluate ICSR data for completeness; code events, medical history, and concomitant medications; compile narrative summaries; follow up on queries; generate expedited regulatory reports; maintain safety tracking; perform literature screening and MedDRA coding; validate xEVMPD product records; manage duplicate ICSRs; ensure document submission to TMF; maintain compliance with SOPs and global regulations.
Seniority
Mid-level, hands-on IC
