International Consultant- Pharmacovigilance Systems Strengthening

The consultant will accelerate implementation of pharmacovigilance IDPs to attain ML3 for vigilance functions in Botswana. The role involves conducting baseline assessments, reviewing guidelines and SOPs, providing guidance on compliance, and supporting training and communication efforts.

Responsibilities

• Conduct a comprehensive baseline GBT assessment and assist in review of guidelines, SOPs, assessment tools, and GBT evidence
• Provide guidance essential for fulfilling identified IDPs
• Integrate GBT IDP implementation to promote compliance by industry, public health entities and national regulatory requirements
• Conduct detailed landscape and SWOT analysis of vigilance systems within BoMRA and related stakeholders
• Review guidelines, SOPs, working tools, and regulatory actions aligned with WHO Global benchmarking standards
• Evaluate Risk Management Planning and related documents, safety communication and vigilance data publication, and vigilance documents during Good Vigilance Inspections
• Provide guidance on communication to BoMRA stakeholders to enhance understanding and compliance to regulations and guidelines
• Deliver monthly progress reports and a comprehensive end of activity report
• Review training materials for safety surveillance and causality assessment
• Recommend sustaining and accelerating progress

Requirements

• Advanced degree in pharmacy, public health, regulatory science, or related field
• Experience working in the medicine regulatory authority/agency
• Over 5 years of relevant work experience in pharmacovigilance, vaccine safety, benefit-risk aggregated report review and risk management planning with a focus on risk minimisation measures
• Experience with WHO Global Benchmarking Tools and/or ICH/EMA guidelines (desirable)
• Expert in the field of pharmacovigilance, vaccine safety and medicine risk management review
• Fluent in English (spoken and written)
• Full medical clearance required for travel

Skills

• Pharmacovigilance
• Vaccine Safety
• Risk Management Planning
• Benefit-Risk Report Review
• Medicine Regulatory Authority Experience
• WHO Global Benchmarking Tool
• ICH Guidelines
• EMA Guidelines
• Regulatory Science
• Pharmacy
• Public Health
• Baseline Assessments
• Guideline Review
• SOP Development
• Compliance guidance
• Training and Support
• Communication Support

Languages

English