04/04/2025 – 04/12/2025
Pharmacovigilance Executive (MICC)
Aufgaben & Verantwortung
Roles & Responsibilities
• Managed full-cycle pharmacovigilance operations within a Medical Information Call
Centre (MICC), handling incoming medical inquiries, adverse events (AEs), product
quality complaints (PQC), and lack of efficacy (LoE).
• Performed ICSR intake, triage, coding (Med DRA/WHO-DD), narrative drafting, and
case classification according to seriousness, expectedness, and causality.
• Conducted quality review of case documentation to ensure completeness,
accuracy, and regulatory compliance with EU GVP, ICH-GCP, US CFR 314.80 &
312.32, and SOPs.
• Managed follow-ups with healthcare professionals and consumers via soft phones,
hard phones, and email, capturing additional information and clarifications for
reporting.
• Collaborated with Regulatory Affairs, Legal, and contract vendors to resolve
safety-related issues, support signal detection, and provide information for
aggregate and ad hoc reports.
• Maintained MICC database integrity, documenting all case activities and ensuring
inspection-ready records.
