About this roleTFS HealthScience is a leading general mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Drug Safety Associateis part of the Project Delivery organization and willwork with assistance on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key ResponsibilitiesSupport to handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients' SOPs and existing demands of the authoritiesMay review cases and write draft narratives of AE and SAE reports, as requiredMay code adverse events,



medical history and concomitant medicationSupport to SAE-reconciliationDCF handlingCorrespondence and archivingAssist in registration and other matters of EudraVigilanceParticipate in relevant project groups/meetingsAssist in internal support to other relevant departmentsMay provide updates of templates for safety handling in specific studies/projects according to relevant SOPsActively contribute to the organization and development of routines to enhance the work at TFSBeing well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issuesQualificationsBachelor's Degree, preferably in life science or nursing; or equivalentAble to work in a fast-paced environment with changing prioritiesUnderstand the basic medical terminology and science associated with the assigned drugs a

📌 Drug Safety Associate (Barcelona)
🏢 Trial Form Support
📍 Barcelona