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 general, 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;

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