Product Safety Associate (m/f/d)

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us! Product Safety Associate (m/f/d) Stellen-ID: 21509 Standort: Frankfurt am Main We are searching intelligent and innovative employees. If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application. Your tasks: - 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 Your profile: - 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 You can expect ... - Experience in exciting and international projects - Continuous salary development - Da Vinci Corporate Benefits - On-the-job training and language courses - Appreciation, motivation and commitment Kontaktdaten für Stellenanzeige Frau Andrea Cindric Da Vinci Engineering GmbH Hauptstätter Straße 149 70178 Stuttgart +49 711 72240 107 apply.job.27237013@hokifyjob.com