Pharmaceutical Safety Expert

hace 1 semana


Colombia Icon A tiempo completo

Job Overview: We are seeking a skilled Senior Drug Safety Associate to join our team at Icon, a leading clinical research organization. In this role, you will be responsible for processing individual case safety reports (ICSRs), conducting coding and assessment of diseases, adverse events, and medications, and submitting safety reports to regulatory authorities.

Estimated Salary: $85,000 - $110,000 per year, depending on location and experience.

About the Role

  1. Receive and process ICSR reports from clinical trials, spontaneous reports, and published literature.
  2. Enter data into company or client safety databases and manage queries.
  3. Perform consistent coding of diseases, adverse events, and medications according to project-specific conventions.
  4. Assess reportability of ICSRs based on project-specific safety reporting assessment sheets.
  5. Submit safety reports to regulatory authorities, IRBs/ECs, and investigational sites in accordance with relevant legislation and contractual agreements.
  6. SUPPORT THE GENERATION OF AGGREGATED SAFETY REPORTS THROUGH DATA RETRIEVAL AND OTHER ASSIGNED TASKS.
  7. Support interim data analysis for DMC reviews.
  8. Respond to inquiries from consumers or healthcare professionals regarding marketed products, triage requests, and process received information in accordance with project-specific instructions.

Requirements

  • Bachelor's degree in health, life sciences, or a related field.
  • Relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety.
  • Knowledge of medical terminology and coding systems.
  • Fluent English language skills, as well as host country language proficiency.

About Icon

At Icon, we value diversity, inclusion, and belonging. Our diverse workforce enables us to better serve our people, patients, customers, and communities. We are committed to providing an inclusive and accessible environment for all candidates and employees. We strive to be a workplace free of discrimination and harassment.


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