12 ago
|
ICON Strategic Solutions
|
Ciudad de México
12 ago
ICON Strategic Solutions
Ciudad de México
Join to apply for the Graduate Pharmacovigilance Associate role at ICON Strategic Solutions.
As a Graduate Pharmacovigilance Associate you will be joining the world’s largest and most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
- Receives and processes individual case safety reports (ICSRs) including serious adverse events, adverse events of special interest, and suspected adverse drug reactions from clinical trials, spontaneous reports 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 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; processes received information in accordance with project-specific instructions.
Qualifications
- 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 the host country language.
What
📌 Graduate Pharmacovigilance Associate (Ciudad de México)
🏢 ICON Strategic Solutions
📍 Ciudad de México