Pharmacovigilance Senior Associate - QA

Job description• Perform the review of quality systems, processes, and procedures with the QA Team Lead for compliance with applicable regulatory regulations andpharmacovigilance guidelines and seek documentation approval from the QA Team Lead and relevant processes.• Review internal controlled documents for compliance.• Support internal and partner pharmacovigilance audits and or inspection when needed.• Responsible with the initiation and facilitation of Phase I internal training programs and shall provide recommendation to team lead after training completion.• Supports in the overall control of documentation and archiving system in a timely manner.• Support in the analysis of quality deviations, identify root causes, and adjudicate Individual Case Safety Report (ICSR) corrections with corresponding issuance ofCorrective action and preventive action, as appropriate.• Contribute to drive continuous process improvement for Quality Assurance.• Support to oversee the in-process workflow of ICSRs.• Support review of the Pharmacovigilance System Master File (PSMF).• Contribute to the review of Pharmacovigilance Agreements.• Performs validation of Operations Key Performance Indicator (KPI) and Metrics data.• Attend and contribute inputs in the QA Meetings.• Support in training and mentoring of QA resources.• Establishing work priorities and direction independently with minimal input from Manager.• Directly report to Team Lead the QA Pharmacovigilance deliverables.• Support and perform duties when specialist is absent or out of the office.• Other duties as assigned by the Quality Assurance Team Lead.