Overview
Pharmacovigilance Pharmacist Jobs in Johannesburg, South Africa at Curiska
Overview : We are seeking a Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across Southern and East Africa. The role involves maintaining quality systems, training staff, and managing safety data.
Key Responsibilities :
Quality Management :
Ensure adherence to GxP, ICH, and pharmacovigilance guidelines. Train staff on SOPs, provide SOPs during audits, report ADRs, and conduct monthly reconciliations.
Training :
Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers, and document training for audits.
Pharmacovigilance System Master File (PSMF) :
Update the PSMF, report audit findings, and manage pharmacovigilance language in contracts.
Audit Scheduling :
Plan and schedule audits for service providers handling pharmacovigilance.
Regulatory Compliance :
Notify Health Authorities of changes, review and adhere to regulatory requirements, compile safety updates, and address compliance issues.
Health Authority Inspections :
Notify management of scheduled inspections related to products.
Corrective and Preventive Actions :
Recommend and oversee implementation of corrective actions from audits or inspections.
Archiving :
Store and archive pharmacovigilance data locally and globally, retain personal and health data as per legislation.
Safety Data Processing :
Process Individual Case Safety Reports (ICSRs), manage safety data, prepare reports, and handle Safety Communications.
Education & Experience :
Degree :
Bachelor of Pharmacy (B. Pharm).
Experience : 1-3 years in pharmacovigilance or drug safety.
Knowledge :
Understanding of regulatory authorities and guidelines in Southern and East Africa.
Knowledge of regulations, ICH guidelines, and Good Clinical Practice (GCP).
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Title: Pharmacovigilance Pharmacist
Company: Curiska
Location: Johannesburg, South Africa
Category: Healthcare (Healthcare Compliance, Pharmacy Technician)
