Regulatory Compliance Specialist

6 days ago


Johannesburg, Gauteng, South Africa Curiska Full time

**Job Summary**

We are Curiska, a dynamic organization in the pharmaceutical industry, seeking a talented Regulatory Compliance Specialist to join our team.

The role involves overseeing product safety and regulatory compliance across Southern and East Africa, ensuring adherence to GxP, ICH, and pharmacovigilance guidelines, and developing and leading training programs.

Responsibilities

  • Ensure adherence to GxP, ICH, and pharmacovigilance guidelines by training staff on SOPs and providing SOPs during audits.
  • Develop and lead pharmacovigilance training programs for new hires and annual refreshers, and document training for audits.
  • Update the Pharmacovigilance System Master File (PSMF), report audit findings, and manage pharmacovigilance language in contracts.
  • Plan and schedule audits for service providers handling pharmacovigilance, notify Health Authorities of changes, and review and adhere to regulatory requirements.
  • Store and archive pharmacovigilance data locally and globally, retain personal and health data as per legislation, and process Individual Case Safety Reports (ICSRs).

Requirements

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


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