Drug Safety Associate

hace 1 semana

Bogotá Cundinamarca, Colombia ICON A tiempo completo

As a Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

**What you will be doing**:
- Receives and processes individual case safety reports ((ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports. This includes: Tracking of received ICSR, entry of ICSR into company or client safety database and query management.- Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.- Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.- Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement.- Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.- Supports interim data analysis for DMC reviews.- Receives inquiries from consumers or healthcare professionals in support of marketed
- products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions.

**You are**:
- Bachelor’s degree in a health, life sciences or other relevant field of study.- All employees must read, write and speak fluent English and host country language.

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

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