Regulatory Compliance Officer

24 hours ago


Johannesburg, Gauteng, South Africa Curiska Full time

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

  1. Quality Management
  • Ensure adherence to GxP, ICH, and pharmacovigilance guidelines.
  • Train staff on SOPs, provide SOPs during audits, report ADRs, and conduct monthly reconciliations.
Training
  • Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers, and document training for audits.
PSMF Management
  • 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
  • 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 Processing
  • 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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