Job Summary
Adverse Drug Reaction (ADR) Monitoring: Collect, assess, document, and report adverse drug reactions and other safety-related information associated with pharmaceutical products.
Case Processing and Safety Reporting: Review individual case safety reports (ICSRs), ensure accurate data entry, and submit reports to regulatory authorities within required timelines.
Drug Safety Surveillance: Monitor safety signals, analyze trends in drug-related risks, and contribute to risk-benefit evaluations for medicines.
Regulatory Compliance Ensure pharmacovigilance activities comply with local and international regulations and guidelines such as those from the World Health Organization, U.S. Food and Drug Administration, or European Medicines Agency.
Preparation of Safety Documentation: Assist in preparing periodic safety update reports (PSURs), risk management plans (RMPs), standard operating procedures (SOPs), and other pharmacovigilance documents.
Requirements
Candidates should possess an HND / B.Sc Degree with 1 - 2 years work experience.