.Drug Safety Officer based in Barcelona - Single sponsorAbout this roleTFS HealthScience is a leading global, 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. As part of our SRS/FSP team, you will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.Key responsibilitiesHandling 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 authoritiesReview and approval of processed cases and AE/SAE reconciliationCoding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug DictionaryQC and approval of coding of adverse event, medical history and concomitant medicationReview and write the safety section in clinical study protocolsReview of clinical trial reports/IBs from a safety perspectiveWrite the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documentsLiterature searchElectronic reporting to EudraVigilanceContribute to plans/instructions and SOPs for post approval surveillanceUpdating of templates for safety handling in specific studies/projects according to relevant SOPsMay act as a Project Lead for Safety-only projectsParticipate in relevant meetings. Forward information to relevant members of the department or study team membersProvide internal support to other relevant departmentsInvolved in improvement projects with other relevant departmentsActively contribute to the organization and development of routines to enhance the work at TFSValidation of computer applications specific for the department with respect to drug safety requirementsBeing 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 issuesEducation and supervision of new Drug Safety personnelParticipate in marketing activitiesRequirementsBachelor's Degree, preferably in life science or nursing; or equivalent3 years ofexperience in the positionAble to work in a fast-paced environment with changing prioritiesUnderstand the medical terminology and science associated with the assigned drugs and therapeutic areasWhat We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.A Bit More About UsOur journey began over 27 years ago in Sweden, in the city of Lund
