PV Officer (Medical Device & Product experience required)

📋 Description

• 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