Safety and Compliance Specialist
1 month ago
Overview
We are seeking a highly skilled Safety and Compliance Specialist to oversee product safety and regulatory compliance across Southern and East Africa.
Key Responsibilities:
- Quality Management: Ensure adherence to GxP, ICH, and pharmacovigilance guidelines. Develop and implement quality systems, provide training to staff, report Adverse Drug Reactions (ADRs), and conduct monthly reconciliations.
- Training and Development: Design and deliver 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: Inform management of scheduled inspections related to products.
- Corrective and Preventive Actions: Recommend and oversee implementation of corrective actions from audits or inspections.
- Data Management: 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.
Requirements:
- Degree: Bachelor of Pharmacy (B. Pharm).
- Experience: 1-3 years in pharmacovigilance or drug safety.
Benefits:
- The successful candidate will be offered a competitive salary range of R600,000 - R800,000 per annum.
- A comprehensive benefits package including medical aid, pension fund, and leave entitlements.
- Opportunities for career growth and professional development.
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