Performing activities in the scope of ICSR management unit within agreed extent and timeframe
Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations
ICSR follow-up and SAE/SUSAR management
Reconciliation (clinical, partners)
Intake, triage, assessment, data entry, follow-up of medical device safety reports
Quality review/QC of medical device cases and data protection

🎯 Requirements

Life science graduate or healthcare qualification with pharmacovigilance experience
Experience in pharmacovigilance and medical device vigilance
Good knowledge of EU MDR (2017/745) and vigilance concepts
Experience with global/European medical device safety databases
Excellent written and verbal communication
Organization, multitasking, planning and time management

🎁 Benefits

Global pharmacovigilance focus at PrimeVigilance
Collaborative and values-driven culture
Opportunities for growth and professional development

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