Safety Assurance Pharmacist
3 weeks ago
About Us: Curiska is a forward-thinking healthcare organization in Southern and East Africa, dedicated to ensuring the highest standards of product safety and regulatory compliance.
Salary: $90,000 - $120,000 per annum, depending on experience.
Job Description:
Role Overview:
We are seeking a highly skilled Safety Assurance Pharmacist to join our team and contribute to the development of our pharmacovigilance strategy.
- Quality Assurance: Ensure that all aspects of product safety and regulatory compliance are met, adhering to GxP, ICH, and pharmacovigilance guidelines.
- Staff Training: Provide regular training to staff on SOPs, develop and lead pharmacovigilance training programs, and conduct local training for new hires and annual refreshers.
- PSMF Management: Update the Pharmacovigilance System Master File (PSMF), report audit findings, and manage pharmacovigilance language in contracts.
- Audit Planning: 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.
- Inspection Response: 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, retain personal and health data as per legislation.
- Safety Data Analysis: Process Individual Case Safety Reports (ICSRs), manage safety data, prepare reports, and handle Safety Communications.
Requirements:
Bachelor of Pharmacy (B. Pharm) degree.
1-3 years of experience in pharmacovigilance or drug safety.
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