6 дней назад
Drug Device Safety Officer II (Pharmacovigilance)
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 (Pharmacovigilance): Managing clinical safety cases, SAE/SUSAR reporting, safety database entries, reconciliation, and regulatory documentation for drug and device studies with an accent on ICH GCP compliance, case quality, and medical assessment. Focus on reviewing safety events, drafting narratives, coordinating with investigators and clinical teams, preparing safety plans and reports, and supporting audits and inspections.
Location: Romania
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Review incoming serious adverse events for accuracy, completeness, and potential safety issues.
- Manage SAE processing and safety reporting, including data entry into safety databases and submission of SAE/SUSAR reports.
- Coordinate with investigator sites, CRAs, data managers, medical directors, and medical monitors to clarify events and reconcile AE/SAE databases.
- Draft safety narratives, safety management plans, periodic safety reports, and compliant protocol and Investigator Brochure safety sections.
- Maintain study documentation, safety databases, eTMF quality, reconciliation plans, and study tracking forecasts.
- Perform quality checks, support audits and inspections, resolve study issues, and mentor new team members.
Requirements
- Bachelor’s degree or graduate qualification in medicine, nursing, pharmacy, life sciences, or a related medical field; an advanced degree is preferred.
- 2–4 years of experience in a medical or safety department, including case processing and safety database experience with AERS, ARISg, Argus, or equivalent systems.
- 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(s) are required.
- Strong communication, negotiation, organization, prioritization, and time-management skills.
- Ability to collaborate, multitask, meet deadlines, and work effectively in a fast-paced environment with changing priorities.
Culture & Benefits
- Flexibility and balance to support personal and professional needs.
- Opportunities to develop skills and grow professionally.
- Collaborative environment where team members’ ideas and input influence ways of working.
- Work contributing to medical innovation and patient safety.
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