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About the role
This role involves processing and analyzing drug safety data to ensure compliance with global pharmacovigilance regulations. The analyst will work with clinical trial and post-marketing data to identify safety signals and prepare regulatory reports.
Required Skills
Preferred Skills
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Responsibilities
- Process Individual Case Safety Reports (ICSRs), Serious Adverse Events (SAEs), and SUSARs in global safety databases.
- Analyze large datasets and clinical trial findings to identify and investigate potential drug safety signals and trends.
- Draft narrative reports and assist in preparing aggregate safety updates, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Engage in pharmacovigilance system master file and risk management system.
- Perform Quality Control (QC) checks on case data ensuring adherence to ICH E2E, Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) guidelines.
- Apply standardized medical terminology (MedDRA, WHODRUG) to adverse events, medical histories, and concomitant medications.
- Communicate safety trends and metrics to medical safety physicians, clinical teams, and regulatory bodies.
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