Job Description
**Overview**:
- As a Graduate Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**Responsibilities**:
**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 ...
- As a Graduate Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**Responsibilities**:
**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 ...
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