Pharmacovigilance Associate
2 weeks ago
Job Role: Senior Pharmacovigilance Associate
- Processing of the Individual Case Safety Reports (ICSR).
- Literature screening activities.
- Accountable for reviewing and assessing the validity of literature abstracts and articles with further processing onto the safety database if required.
- Extended Eudravigilance Medical Product Dictionary (XEVMPD) maintenance and EVWEB updates including Summary of Product Characteristics (SPC/SmPC), Patient Information Leaflet (PIL) inserts and updates.
- Preparation of Signal Detection Reports and Addendum to Clinical Overview (ACO).
- Perform the review of SmPC and PIL in comparison to reference products.
- Monitor the safety updates on safety signals for the client products.
- Compliance to the standard operating procedures (SOPs) and regulations.
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