Safety & PV Specialist
Core
Process, track, and report Individual Case Safety Reports (ICSRs) to ensure patient safety and regulatory compliance across clinical and post-marketing programs.
Role type
Pharmacovigilance Safety Specialist
Builds
Safety databases, regulatory reports, and case narratives for life-science therapies
Domain
Life sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Medical coding (MedDRA), ICSR processing, regulatory reporting, literature screening, data quality assurance, xEVMPD validation, duplicate management
Preferred skills
Knowledge of GCP/GVP guidelines, familiarity with safety database systems, experience with SPOR/IDMP standards
Technologies
Microsoft Office Suite, Visio, safety database systems
Responsibilities
Enter and track safety information in PV systems; Triage and evaluate ICSRs for completeness and reportability; Code adverse events and medical history; Prepare case narratives and manage follow-up queries; Generate expedited safety reports; Perform literature screening and maintain drug dictionaries; Validate xEVMPD product records; Manage duplicate ICSRs; Conduct quality reviews of cases; Maintain documentation in TMF and PSMF.
Seniority
Individual Contributor