Premier Research is looking for a Drug Device Safety Officer II to join our Pharmacovigilance and Records Management team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.national regulations and SOP’s applicable for specific projects. Review incoming SAEs for accuracy, completeness and potential safety issues. Drafts narratives per guidelines and/or individual contract agreements. Enters relevant data from safety reports to safety database. Complete SAE management and safety reporting for approximately 80% of billable time. Review and approve reconciliation plans as Lead DSO Work with Data Managers / Medical Directors/CRAs during the reconciliation of AE/SAE databases prior to client data delivery. Prepare draft Safety Management Plan for Safety Manager review. Prepare for and participate in audits and inspections by sponsors or regulatory agencies Track study progress, proactively resolve issues, and propose corrective action to project teams/clients Perform quality check of SAEs processed by other DSO, both in paper and in safety database (if applicable)



Maintain/support maintenance of safety database for specific projects Work with Medical Monitor/ Medical Director to determine appropriate assessments with regard to relationship of event to the investigational product and regulatory reporting status of SAEs. QC eTMF Enter monthly actuals and determine forecasting in Premier Research’s financial tool for accurate study tracking Supports preparation of periodic safety reports (periodic line listings, DSURs, ASRs) Evaluate safety sections of the protocol and Investigator Brochures (IBs) to ensure the text is compliant with regulations and escalate as appropriate. Eudravigilance, Toetsing online (if applicable) Mentors and trains new employees and other team members What we are Looking for: Bachelor degree or graduate in medical or related fields (e.g. medicine, nursing, pharmacy, life sciences), advanced degree preferable. 2-4 years of working in a medical or safety department with demonstrable knowledge of medical terminology and experience of handling case processing and safety databases (AERS/ARISg/Argus) or equivalent role within medical. Knowledge of ICH / GCP regulations Working knowledge of FDA Guidance Documents / EU Directives / ISO 14155 standard, drug / device development, and clinical monitoring procedures Knowledge of web based communication tools for conferences Fluent verbal and written English as well as the local language(s) Excellent team player, collaborative and able to build an effective team. SummaryLocation: SpainType: Full time

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