6 дней назад
Drug Device Safety Officer II (MedTech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Drug Device Safety Officer II (MedTech): Managing safety cases and regulatory reporting for drug and device clinical studies with an accent on SAE review, safety database processing, and ICH/GCP compliance. Focus on reconciling safety data, preparing narratives and periodic safety reports, supporting audits, and submitting SAE/SUSAR reports through regulatory platforms.
Location: Slovakia
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Review incoming serious adverse events (SAEs) for accuracy, completeness, and potential safety issues.
- Clarify event details with investigator sites and CRAs, draft case narratives, and enter safety data into relevant databases.
- Manage SAE reporting, including SAE/SUSAR submissions through dedicated platforms such as EudraVigilance.
- Coordinate reconciliation of AE/SAE databases with Data Managers, Medical Directors, CRAs, and other project stakeholders.
- Prepare safety management plans and support periodic safety reports, audits, inspections, and eTMF quality control.
- Perform quality checks, maintain study documentation, track progress, support forecasting, and mentor new team members.
Requirements
- Bachelor’s degree or graduate qualification in medicine, nursing, pharmacy, life sciences, or a related field; an advanced degree is preferred.
- 2–4 years of experience in a medical or safety department, including case processing, medical terminology, and safety databases such as AERS, ARISg, Argus, or equivalent.
- Knowledge of ICH and GCP regulations, FDA guidance documents, EU directives, ISO 14155, drug and device development, and clinical monitoring procedures.
- Fluent written and verbal English and the local language or languages are required.
- Strong communication, negotiation, organizational, time-management, multitasking, and prioritization skills.
- Collaborative, dependable, accountable, customer-focused, and able to work effectively in a fast-paced environment.
Culture & Benefits
- Opportunities for professional growth, skills development, and career progression.
- Flexible working practices designed to support work-life balance.
- Collaborative environment where team members can influence ways of working.
- Work connected to medical innovation and the development of medicines, devices, and diagnostics.
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