Drug Device Safety Officer I

Overview In this role you help turn life-changing ideas in biotech, medtech, and specialty pharma into safe medicines, devices, and diagnostics. You will work closely with cross-functional teams to ensure regulatory compliance and robust safety documentation. You will manage safety narratives, SAE reporting, and data reconciliation to support sponsor audits and inspections. This position offers growth, collaborative culture, and meaningful patient impact, with a focus on delivering timely, high-quality pharmacovigilance deliverables. Compensaciones / Beneficios growth opportunities flexible work-life balance collaborative culture meaningful patient impact Responsabilidades Ensure compliance with ICH GCP, ICH E2A, national regulations, and SOPs for projects Review incoming SAEs for accuracy and safety concerns Collaborate with Investigator Sites/CRAs to resolve outstanding event issues for follow-up reports Draft narratives per guidelines/contract agreements Enter data from safety reports into the safety database Manage SAE reporting for ~90% of billable time Coordinate with Data Managers/Medical Directors/CRAs on AE/SAE database reconciliation File documents according to standard filing systems (paper and electronic) Support Safety Management plan preparation and review SAE Reconciliation Plans Assist preparations for audits and inspections by sponsors/regulators Monitor study progress, identify issues, and propose corrective actions to Safety Manager and PV team Carry out other designated activities and deputize for Project Lead DSO Requisitos principales ~0-2 years in a relevant pharma or medical field (e.g., CRA, Pharmacy) ~ Knowledge of ICH/GCP regulations ~ Working knowledge of FDA Guidance Documents / EU Directives / ISO 14155 ~ Knowledge of web-based communication tools for conferences ~ Fluent verbal and written English and local language(s) ~ Excellent teamwork, collaboration, and ability to multitask in a fast-paced environment ~ Strong verbal and written communication and negotiation skills ~ Excellent organizational and time-management skills; ability to prioritize to meet deadlines ~ Accountable, dependable, and customer-service oriented team player collaborative multitasking ICH GCP SAE management and safety reporting pharmacovigilance processes