Pharmacovigilance Associate Position
Core
Process adverse events and special situation cases to ensure timely, accurate, and compliant Individual Case Safety Report (ICSR) intake, processing, reporting, and reconciliation.
Role type
Associate pharmacovigilance specialist (case processing)
Builds
Individual Case Safety Reports (ICSRs) and safety data reconciliations
Domain
Life sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
ICSR case processing, MedDRA coding, WHO Drug coding, data entry, narrative writing, data quality control, regulatory reporting assessment, data reconciliation, workflow monitoring, cross-functional collaboration
Preferred skills
None stated
Technologies
Safety databases, MedDRA, WHO Drug
Responsibilities
Process adverse events and special situation cases (intake, triage, data entry, follow-up, narrative writing, coding, and quality review); Perform medical coding using MedDRA and WHO Drug; Ensure timely regulatory reporting and distribution activities; Conduct case quality control (QC) and resolve data queries; Support safety database activities including case lifecycle management and data cleaning; Reconcile safety data with clinical, medical information, product quality, and/or partner sources; Participate in operational metrics tracking and propose process improvements; Collaborate cross-functionally to obtain follow-up information and query resolutions; Support inspections/audits by ensuring accurate documentation; Contribute to the maintenance and continuous improvement of pharmacovigilance processes; Support cross-functional safety data review meeting activities.
Seniority
Junior, hands-on IC
