Pharmacovigilance Specialist

24 hours ago


Johannesburg, Gauteng, South Africa Curiska Full time

About Curiska

We are a leading company in the field of pharmacovigilance, dedicated to ensuring the highest standards of product safety and regulatory compliance across Southern and East Africa.

Job Summary

We are seeking an experienced Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across our region. The ideal candidate will have a strong background in pharmacovigilance or drug safety, with excellent knowledge of regulatory authorities and guidelines in Southern and East Africa.

Key Responsibilities

  • Maintain quality systems and 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.
  • 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.

Education & Experience

  • Bachelor of Pharmacy (B. Pharm) degree.
  • 1-3 years of experience in pharmacovigilance or drug safety.

Requirements

  • Excellent knowledge of regulatory authorities and guidelines in Southern and East Africa.
  • Knowledge of regulations, ICH guidelines, and Good Clinical Practice (GCP).
  • Proficiency in medical writing and submissions.

Compensation Package

The estimated salary for this position is $80,000 - $110,000 per year, depending on experience.



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