Senior Pharmacovigilance Expert
2 weeks ago
Job Title: Global Pharmacist Safety Specialist
About the Role: Curiska is seeking a skilled Pharmacovigilance Pharmacist to lead product safety and regulatory compliance across Southern and East Africa.
Key Responsibilities:
- Quality Management: Ensure adherence to GxP, ICH, and pharmacovigilance guidelines, train staff on SOPs, and conduct monthly reconciliations.
- Training: Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers.
- PSMF Management: Update Pharmacovigilance System Master File, 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, and compile safety updates.
- Health Authority Inspections: Notify management of scheduled inspections related to products.
- Corrective Actions: Recommend and oversee implementation of corrective actions from audits or inspections.
- Archiving: Store and archive pharmacovigilance data locally and globally.
- Safety Data Processing: Process Individual Case Safety Reports, manage safety data, and prepare reports.
Requirements: Bachelor of Pharmacy (B. Pharm), 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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