Senior Drug Safety Associate

hace 3 días

Colombia ENGINEERINGUK A tiempo completo

As a Senior 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 true 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 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 complaint, 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.
  • The successful candidate will have relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
  • 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.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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