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