Safety & PV Specialist I or II previous experience in medical devices - CPQA - Remote Mexico
Core
Pharmacovigilance specialist managing individual case safety reports (ICSRs), safety databases, and regulatory submissions for medical devices and life sciences products.
Role type
Pharmacovigilance Specialist (IC)
Builds
Safety databases, regulatory reports (expedited), and TMF/PSMF documentation for clinical trials and post-marketing programs.
Domain
Life Sciences / Medical Devices / Pharmacovigilance
Deliverable
Dashboards & analysis
Required skills
ICSR triage and processing, MedDRA coding, xEVMPD record validation, literature screening, regulatory compliance (GCP/GVP), safety database management
Preferred skills
None stated
Technologies
Safety databases, Microsoft Office Suite, Visio, Team Share
Responsibilities
Enter and track ICSRs in quality systems, triage and evaluate ICSR data for completeness and accuracy, code events and medical history using MedDRA, compile narrative summaries, manage duplicate ICSR identification, validate and submit xEVMPD product records, ensure document submission to Trial Master File and Pharmacovigilance System Master File, maintain compliance with global regulations and SOPs.
Seniority
Individual Contributor