Drug Device Safety Officer II (Pharmacovigilance)

Location: Spain

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical 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.
• Coordinate with investigator sites, CRAs, Data Managers, Medical Directors, and Medical Monitors to clarify events and reconcile AE/SAE databases.
• Draft safety narratives, prepare Safety Management Plans, and support periodic safety reports such as DSURs and ASRs.
• Enter and quality-check safety data in databases including AERS, ARISg, Argus, or equivalent systems.
• Submit SAE/SUSAR reports through platforms such as EudraVigilance and support audits, inspections, filing, and eTMF quality control.
• Track study progress, resolve issues, propose corrective actions, 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, medical terminology, and safety databases.
• Knowledge of ICH and GCP regulations, FDA guidance, EU directives, ISO 14155, drug/device development, and clinical monitoring procedures.
• Fluent written and verbal English and the local language(s) are required.
• Strong communication, negotiation, organization, time-management, prioritization, and multitasking skills.
• Collaborative, accountable, dependable, customer-focused, and able to work effectively in a fast-paced environment.

Culture & Benefits

• Flexible work practices intended to support work-life balance.
• Opportunities to develop skills and grow professionally.
• Collaborative environment where team members can influence working practices.
• Work focused on medical innovation and improving patient outcomes.