Senior Drug Safety Associate
hace 1 mes
As a Senior Drug Safety Associate, you will be part of a dynamic team at ICON, working on clinical research projects that make a real difference in people's lives. Your primary responsibility will be to receive, process, and analyze individual case safety reports (ICSRs) from clinical trials, spontaneous reports, and published literature. This includes tracking received ICSR, entry into our safety database, and query management.
Key Responsibilities
- Coding of diseases, adverse events, and medications according to project-specific guidelines in our safety database.
- Assessing reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
- Preparation and submission of safety reports to Regulatory Authorities, IRBs/ECs, and investigational sites as per relevant legislation and contractual agreements.
- Supporting the generation of Aggregated Safety Reports through data retrieval and other assigned tasks.
- Interim data analysis for DMC reviews.
- Triage and processing of consumer or healthcare professional inquiries related to marketed products.
Requirements
- Bachelor's degree in a health, life sciences, or relevant field of study.
- Relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
- Fluency in English and host country language.
About ICON
At ICON, we're committed to building a diverse culture that rewards high performance and nurtures talent. Our benefits are designed to be competitive within each country, focused on well-being and work-life balance opportunities for you and your family.
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