• Reconciliation & Compliance: Regular reconciliation with distribution partners, affiliates, and external service providers; investigation and resolution of discrepancies, request and follow-up of RCA/CAPAs, escalation in case of repeated compliance breaches
• Safety Inbox & Triage: Identification, registration, prioritization, and duplicate check of incoming ICSRs (Medical Devices and Cosmetics); forwarding safety-relevant information to internal teams, partners, and service providers
• Outsourcing & Case Processing: Daily transfer of ICSRs to external providers, handling case-related queries; processing and quality control of clinical study SAEs, including MedDRA/IMDRF coding
• Distribution of Reports & Authority Requests: Forwarding of spontaneous adverse event reports and study reports to partners and PRRCs; support for regulatory submissions in compliance with national and international laws
• Invoice Verification: Detailed review of monthly invoices from external service providers to ensure task completion, accuracy, and timeliness
• SOP Management: Development, review, and implementation of SOPs according to applicable regulations (e.g., MPG, MDR, ISO standards)
• Audit Support: Support of auditees during preparation and throughout audits

 

• Scientific university degree OR Training as nurse, pharmaceutical technician, medical documentalist or similar
• Several years of product safety experience within the pharmaceutical or medical device industry
• Profound knowledge of medical device regulations in EU, Profound knowledge in the processing of ICSRs and in medical coding systems (MedDRA + IMDRF)
• Prior safety database experience
• Independent, analytical and conceptual work, Careful, reliable way of working
• Fluent in English in speech and writing

• Experience in exciting and international projects
• Continuous salary development
• Da Vinci Corporate Benefits
• On-the-job training and language courses
• Appreciation, motivation and commitment

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!