Safety Associate

We are partnering with a medical device CRO to appoint a Safety Associate to support EU clinical trials.This is an exciting opportunity for an experienced safety professional to join a collaborative, international team working at the forefront of medical device clinical research.Location: Fully Remote (Europe)Hours: 30 hours per weekThe OpportunityAs the Safety Associate, you will play a key role in ensuring safety oversight across EU-based clinical trials and supporting international studies involving EU sites. You will work closely with project management, medical monitoring, and global safety teams to ensure compliance with applicable regulations and patient safety requirements.Key ResponsibilitiesAct as the Safety Associate for EU clinical trials and support international studies involving EU clinical sitesReview safety events within the EDC, including AEs, SAEs, and device deficiencies, raising queries where requiredReview protocol deviations and assess potential safety impactReview source documentation and prepare AE narratives for SAEs and events potentially related to device and/or procedureDraft key study safety documentation, including Safety Management Plans, CEC Charters, and DSMB ChartersPerform safety reporting in accordance with MDCG guidance and local regulatory requirementsCollaborate closely with EU Project Management, Medical Monitors, and US-based Safety teamsRequirementsPrevious experience in clinical safety/pharmacovigilance within a CRO, medical device, or clinical research environmentExperience supporting clinical trials, ideally within medical devicesStrong understanding of AE/SAE reporting and clinical safety documentationFamiliarity with EU regulatory requirements and MDCG guidance preferredGerman language skills (reading and speaking) are essentialAbility to work independently in a fully remote, international environmentIf you are interested in hearing more, please apply or reach out directly for a confidential discussion.