Regulatory Compliance Professional
1 day ago
About Us: Curiska is a reputable healthcare organization in Southern and East Africa, committed to upholding the highest standards of regulatory compliance and product safety.
Salary: $100,000 - $130,000 per annum, depending on experience.
Job Description:
Responsibilities:
We are seeking a seasoned Regulatory Compliance Professional to ensure that our operations meet the required standards of regulatory compliance and product safety.
- Regulatory Knowledge: Stay up-to-date with regulatory authorities and guidelines in Southern and East Africa, ensuring compliance with GxP, ICH, and pharmacovigilance guidelines.
- Training Programs: Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers, and document training for audits.
- PSMF Management: Update the Pharmacovigilance System Master File (PSMF), report audit findings, and manage pharmacovigilance language in contracts.
- Audit Scheduling: Plan and schedule audits for service providers handling pharmacovigilance.
- Compliance Monitoring: 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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