Drug Safety Associate

hace 3 semanas


Bogotá, Bogotá D.E., Colombia Icon A tiempo completo

As a Drug Safety Associate at ICON, you will be working in a dynamic and global environment, partnering with pharmaceutical companies to develop treatments that improve and save lives. Your role will involve receiving and processing individual case safety reports (ICSR) from clinical trials, spontaneous reports, and published literature. This includes tracking received ICSR, entering them into the safety database, and managing queries. You will also be responsible for coding diseases, adverse events, and medications consistent with project-specific coding conventions. Additionally, you will assess the reportability of ICSRs based on the project-specific safety reporting assessment sheet and submit safety reports to regulatory authorities, IRBs/ECs, and investigational sites in accordance with relevant legislation and contractual agreements. Your expertise will also be utilized in generating aggregated safety reports and supporting interim data analysis for DMC reviews. To be successful in this role, you will require a bachelor's degree in a health, life sciences, or relevant field and relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems. What ICON can offer you: Our company values diversity, inclusion, and belonging, and we are committed to creating an environment that is inclusive and accessible for all candidates. We offer a competitive salary, a range of additional benefits, and opportunities for professional growth and development.



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