Regulatory Compliance Professional

1 day ago


Johannesburg, Gauteng, South Africa Curiska Full time
Job Title: Regulatory Compliance Professional

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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