Posted:1 day ago|
Platform:
Work from Office
Full Time
The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A key responsibility includes the preparation and maintenance of Risk Management Plans (RMPs), which involve identifying potential risks, outlining mitigation strategies, and ensuring regulatory compliance. Continuous monitoring of safety updates and detection of safety signals for client products is essential. All activities must be conducted in strict compliance with standard operating procedures (SOPs) and applicable regulatory requirements.
Eudravigilance, XEVMPD Maintenance, and EVWEB Updates
Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
Risk Management Plan (RMP) and Regulatory Documentation
ICSR Processing and Reference Product Comparison
G S S Pharma
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