Overview

In this role you ensure regulatory compliance and oversee safety reporting for medical products. You will manage SAE processing, ensure data quality, and support audits while collaborating with cross-functional teams to deliver safety insights. The position sits at the intersection of pharmacovigilance, medical oversight, and client delivery, contributing to life-saving therapies and devices. You will evolve safety processes and help maintain high standards across projects. This role offers growth in a integral, patient-focused environment focused on medical innovation.

Responsabilidades

Review incoming SAEs for accuracy and safety issues Collaborate with Investigators/CRAs to finalize follow-up data Draft narratives per guidelines and contracts Enter SAE data into safety databases Lead SAE management and safety reporting for ~80% of billable time Review and approve reconciliation plans as Lead DSO CoordinateAE/SAE database reconciliation with Data Managers/Medical Directors/CRAs Ensure proper filing of documents (paper and electronic)



Prepare Safety Management Plan drafts Prepare for audits and inspections by sponsors/regulators Track study progress, propose corrective actions Quality check SAEs processed by others and maintain safety databases Determine event-product relationship with Medical Monitor/Medical Director QC eTMF Enter monthly actuals and forecast in financial tool Support preparation of periodic safety reports (DSURs, ASRs) Evaluate protocol/IB safety sections for regulatory compliance Submit SAE/SUSAR via submission platforms (e.g., Eudravigilance) Mentor and train new team members

Requisitos principales

Bachelor in medical or related field; advanced degree preferable 2-4 years in medical or safety department with SAE processing and safety databases experience Knowledge of ICH/GCP regulations Working knowledge of FDA Guidance/EU Directives/ISO 14155 Experience with web-based conference tools Fluent in English and local language(s) team player; collaborative multitasking and time management strong written and verbal communication SAE/AE processing Safety databases (AERS/ARISg/Argus) EudraVigilance submission

📌 Drug Device Safety Officer II (Valladolid)
🏢 Premier Research
📍 Valladolid