Senior Drug Safety Associate
hace 1 mes
As a Senior Drug Safety Associate at ENGINEERINGUK, you will be part of a world-class team that is dedicated to ensuring the safety of patients and advancing the field of pharmacovigilance.
Key Responsibilities:- Process and analyze individual case safety reports (ICSRs) from clinical trials, spontaneous reports, and published reports.
- Perform coding of diseases, adverse events, and medications according to project-specific coding conventions.
- Assess reportability of ICSRs based on project-specific Safety Reporting Assessment sheets.
- Submit safety reports to regulatory authorities, IRBs/ECs, and investigational sites in accordance with relevant legislation and project-specific contractual agreements.
- Support the generation of aggregated safety reports through data retrieval and other assigned tasks.
- Support interim data analysis for DMC reviews.
- Respond to inquiries from consumers or healthcare professionals in support of marketed products.
- Bachelor's degree in a health, life sciences, or other relevant field of study.
- Relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
- Fluent English and host country language skills.
At ENGINEERINGUK, we value diversity, inclusion, and belonging. We are committed to providing an inclusive and accessible environment for all candidates and employees.
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Senior Drug Safety Associate
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