Pharmacovigilance Data Analyst
Unique Pharmaceuticals Limited
Core Responsibilities:
- Data Processing & Case Management: Process Individual Case Safety Reports (ICSRs), Serious Adverse Events (SAEs), and SUSARs in global safety databases.
- Safety Analysis & Signal Detection: Analyze large datasets and clinical trial findings to identify and investigate potential drug safety signals and trends.
- Regulatory Reporting: Draft narrative reports and assist in preparing aggregate safety updates, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Engages in pharmacovigilance system master file and risk management system
- Data Quality & Compliance: Perform Quality Control (QC) checks on case data ensuring adherence to ICH E2E, Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) guidelines.
- Medical Coding: Apply standardized medical terminology (MedDRA, WHODRUG) to adverse events, medical histories, and concomitant medications
- Cross-Functional Collaboration: Communicate safety trends and metrics to medical safety physicians, clinical teams, and regulatory bodies.
Key Qualifications & Skills
- Education: Bachelor’s Degree or higher in Medicine, Pharmacology, Pharmacy, Nursing, Life Sciences, Statistics, or Public Health.
- Technical Software: Proficiency in specialized drug safety systems (e.g., Oracle Argus), coding terminology (e.g., MedDRA, WHODRUG), and data analysis tools (e.g., SAS, R, SQL, or Python).
- Experience: 2 - 4 years of experience in pharmacovigilance, drug safety data analysis, or a clinical research environment.
- Regulatory Knowledge: Solid understanding of ICH (E2A, E2B, E2E), and GVP guidelines.
Application Closing Date
6th August, 2026.
Method of Application
Interested and qualified candidates should send their CV to: View email address on hotnigerianjobs.com using the Job Title as the subject of the mail.
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Vacancy posted 10 hours ago
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