About this role TFS Health Science 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 Responsibilities
Support 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 authorities May review cases and write draft narratives of AE and SAE reports, as required May code adverse events,



medical history and concomitant medication Support to SAE-reconciliation DCF handling Correspondence and archiving Assist in registration and other matters of Eudra Vigilance Participate in relevant project groups/meetings Assist in internal support to other relevant departments May provide updates of templates for safety handling in specific studies/projects according to relevant SOPs Actively 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 issues Qualifications Bachelor's Degree, preferably in life science or nursing; or equivalent Able to work in a fast-paced environment with changing priorities Understand the basic medical terminology and science associated with th

📌 Drug safety associate (Barcelona)
🏢 Jobrapido
📍 Barcelona