Drug Safety Associate

hace 2 semanas

Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo
About the Role

This is an exciting opportunity to join ICON plc, a leading clinical research organization, as a Drug Safety Associate. As a key member of our team, you will play a crucial role in ensuring the safety of patients participating in clinical trials.

Key Responsibilities
  • Process and manage individual case safety reports (ICSRs) from clinical trials, spontaneous reports, and published reports.
  • Perform consistent 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 contractual agreements.
  • Support the generation of aggregated safety reports through data retrieval and other assigned tasks.
  • Support interim data analysis for DMC reviews.
  • Receive and process inquiries from consumers or healthcare professionals in support of 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.
  • Fluent English and host country language skills.
About ICON

At ICON, we value diversity, inclusion, and belonging. We strive to create a workplace that is inclusive and accessible for all candidates. We are committed to providing equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Interested in this role, but unsure if you meet all the requirements? We encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON.

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