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 (Valencia)
🏢 Premier Research
📍 Valencia
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