Drug Device Safety Officer II (Pharmacovigilance)

Location: Bulgaria

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.

What you will do

• Review incoming SAEs for accuracy, completeness, safety issues, and regulatory reporting status.
• Coordinate with investigator sites, CRAs, Medical Directors, Medical Monitors, and Data Managers to clarify events and reconcile AE/SAE databases.
• Draft safety narratives, prepare Safety Management Plans and periodic safety reports, and submit SAE/SUSAR reports through dedicated platforms.
• Enter and maintain safety data in databases such as AERS, ARISg, Argus, or equivalent systems.
• Maintain study documentation, perform eTMF and SAE quality checks, and support audits and regulatory inspections.
• Track study progress, support forecasting and financial tracking, resolve 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.
• Knowledge of ICH/GCP regulations, FDA guidance, EU directives, ISO 14155, drug and device development, and clinical monitoring procedures.
• Fluent written and verbal English and the local language are required.
• Strong communication, negotiation, organizational, time-management, prioritization, and multitasking skills.
• Collaborative, dependable, accountable, customer-focused, and able to work in a fast-paced environment with changing priorities.

Culture & Benefits

• Flexible working approach supporting work-life balance.
• Opportunities to develop skills and advance professionally.
• Collaborative environment where team members’ ideas and input influence ways of working.
• Work connected to medical innovation and improving patient outcomes.