Clinical Trial Safety Scientist

hace 18 horas


Madrid, España IQVIA A tiempo completo

Responsibilities Ensure consistent processes and efficient review of critical clinical/safety dataReview of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closurePrepare aggregated data visualization and facilitate meetings related to review of safety data on study levelContribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)Serve as a member of the Extended Study Team and report on TRISARC deliverablesWork with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluationEscalate urgent and critical medical cases to the study physician/medical scientist as appropriateProvide input into the process of setting automated patient narratives, if applicableProvide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicableLead quality of own deliverablesTake on tasks as assigned by the Directors, Associate Directors Clinical Trial SafetyProvide input into non-drug project work including training activities, continuous improvement and development of procedures as neededEducation/Experience Educational degree (BSc/MSc/PhD) in Life Science or equivalent work experience in directly related fieldsMinimum 4+ years of experience in Pharmacovigilance / Drug SafetyUnderstanding of the clinical study and drug development processKnowledge of ICH/GCP GuidelinesKnowledge of SAE reporting requirementsExperience using data review tools is preferredQuality focus, analytical skills, and ability to concisely summarize large amounts of complex informationProven ability to prioritize and manage multiple tasks with conflicting deadlinesExcellent time managementVery good interpersonal and communication skillsTeam player, able to work individuallyAbility and willingness to work cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas#J-18808-Ljbffr



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