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).
- Proficiency in medical writing and submissions.
