International Consultant- Pharmacovigilance Systems Strengthening
Organizational Context
The World Health Organization (WHO) Country Office in Botswana is seeking an International Consultant to strengthen pharmacovigilance systems. This role will support the Botswana Medicines Regulatory Authority (BoMRA) in enhancing its capacity for drug safety monitoring and risk management, contributing to public health protection within Botswana.
Job Purpose
The purpose of this role is to accelerate the implementation of pharmacovigilance initiatives in Botswana, aiming to achieve a higher level of vigilance functions (ML3). The consultant will conduct a comprehensive baseline assessment of existing systems, review and provide guidance on guidelines, Standard Operating Procedures (SOPs), and assessment tools. A key focus will be on evaluating Risk Management Plans (RMPs) and related documents, ensuring alignment with WHO Global benchmarking standards. The role also involves integrating these improvements to promote compliance among industry stakeholders, public health entities, and regulatory authorities, ultimately enhancing the overall safety of medicines and vaccines in the country.
Responsibilities
The consultant will conduct a detailed landscape and SWOT analysis of pharmacovigilance systems within the Botswana Medicines Regulatory Authority (BoMRA) and relevant stakeholders. This includes reviewing existing guidelines, Standard Operating Procedures (SOPs), and assessment tools to ensure alignment with WHO Global benchmarking standards. A significant part of the role involves evaluating Risk Management Planning (RMP) and related documents, providing expert recommendations for improvement. The consultant will also assess vaccine safety monitoring practices and contribute to the development or refinement of risk minimization measures. Furthermore, the role requires integrating these pharmacovigilance improvements to foster compliance among industry, public health entities, and national regulatory bodies, thereby strengthening the overall drug safety framework in Botswana.
Work Experience
Essential: More than 5 years of relevant work experience in a medicine regulatory authority/agency, with a strong focus on pharmacovigilance, vaccine safety, benefit-risk aggregated report review, and risk management planning, including risk minimization measures. Desirable: Experience with WHO Global Benchmarking Tools and/or ICH/EMA guidelines.
Skills
Expertise in pharmacovigilance, vaccine safety, and medicine risk management review. Experience with risk minimization measures. Familiarity with WHO Global Benchmarking Tools and ICH/EMA guidelines is desirable.