Experteer Overview
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In this role you ensure regulatory compliance and quality in safety reporting for biotech, medtech, and specialty pharma projects. You’ll collaborate with sites, CRAs, and medical directors to manage SAE data and prepare safety narratives, supporting audits and PV processes. You will work in a fast-paced environment, helping to deliver safe medical innovations. This position offers growth within a dedicated pharmacovigilance and records management team.
Compensaciones / Incentivos
• Ensure compliance with ICH GCP, ICH E2A, and applicable SOPs across projects
• Review SAEs for accuracy and safety implications
• Coordinate with Investigator Sites/CRAs to resolve event issues for follow-up
• Draft narratives per guidelines and contracts
• Enter safety data into the safety database
• Manage SAE processes and safety reporting for ~90% of time billed
• Collaborate with Data Managers/Medical Directors/CRAs on AE/SAE database reconciliation before client delivery
• File documents per standard filing systems (paper and electronic)




• Support draft Safety Management Plans and SAE Reconciliation Plans
• Prepare for audits and inspections by sponsors or regulatory bodies
• Monitor study progress, identify issues, and propose corrective actions to Safety Manager and PV team
• Role may deputize for project Lead DSO
• Other activities as designated
Responsabilidades
• 0-2 years in a related pharma/medical field or role (e.g., CRA, Pharmacy)
• Knowledge of ICH/GCP regulations
• Working knowledge of FDA guidance, EU directives, xqbhyrx ISO 14155, and clinical monitoring procedures
• Knowledge of web-based communication tools for conferences
• Fluent English and local languages
• Strong collaboration and teamwork skills
• Ability to multitask in a fast-paced environment with changing priorities
• Strong verbal and written communication and negotiation skills
• Excellent organizational and time-management abilities
• Customer service oriented and positive, results-driven
• Dependable and accountable
Requisitos principales
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📌 Drug Device Safety Officer I (España)
🏢 Premier Research
📍 España