Regulatory Compliance Officer
24 hours ago
Overview
Curiaska is a leading organization in the field of pharmacovigilance, committed to delivering high-quality services across Southern and East Africa.
Job Description
We are seeking a skilled Pharmacovigilance Pharmacist to join our team. As a key member of our regulatory compliance department, you will be responsible for ensuring the highest standards of product safety and regulatory compliance across our region.
Main 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.
- Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers, and document training for audits.
- Update the PSMF, report audit findings, and manage pharmacovigilance language in contracts.
- Plan and schedule audits for service providers handling pharmacovigilance.
- Notify Health Authorities of changes, review and adhere to regulatory requirements, compile safety updates, and address compliance issues.
- Notify management of scheduled inspections related to products.
- Recommend and oversee implementation of corrective actions from audits or inspections.
- Store and archive pharmacovigilance data locally and globally, retain personal and health data as per legislation.
- Process Individual Case Safety Reports (ICSRs), manage safety data, prepare reports, and handle Safety Communications.
Required Qualifications
- Bachelor of Pharmacy (B. Pharm) degree.
- 1-3 years of experience in pharmacovigilance or drug safety.
Competitive Salary Package
The estimated salary for this position is $80,000 - $110,000 per year, depending on experience.
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