Consultants Pharmacovigilance Systems Strengthening
Organizational Context
The World Health Organization (WHO) Country Office in Botswana, under the AF_BWA department, is seeking a Consultant to strengthen pharmacovigilance systems. This role is crucial for ensuring the safety and efficacy of medical products within Botswana, contributing to public health by enhancing regulatory oversight and compliance.
Job Purpose
The primary purpose of this consultancy is to conduct a comprehensive assessment and provide recommendations for strengthening pharmacovigilance systems in Botswana. This involves evaluating the current landscape, identifying gaps against WHO standards, and developing strategies for improvement. The role will contribute to enhancing the national regulatory authority's capacity to monitor and manage the safety of medicines, ultimately protecting public health by ensuring that medicines available in the country are safe and effective. The consultant will play a key role in developing actionable plans and guidance to improve understanding and compliance with pharmacovigilance regulations among stakeholders.
Responsibilities
The consultant will conduct a detailed landscape and SWOT analysis of existing pharmacovigilance systems within the Botswana Medicines Regulatory Authority (BoMRA) and relevant stakeholders. This includes reviewing current guidelines, Standard Operating Procedures (SOPs), working tools, and regulatory actions to ensure alignment with WHO Global benchmarking standards. A key responsibility is to evaluate Risk Management Plans (RMPs) and related documents, as well as safety communication and vigilance data publication processes. The consultant will also assess the implementation of Individual Development Plans (IDPs) at Adverse Drug Reaction Monitoring Centres (AMCs) against established field visit manuals. Finally, the consultant will provide guidance to BoMRA stakeholders on activities designed to enhance understanding and compliance with pharmacovigilance regulations and guidelines.
Work Experience
Significant experience in pharmacovigilance systems strengthening, regulatory affairs, or drug safety is essential. Experience working with national regulatory authorities, particularly in resource-limited settings, and familiarity with WHO guidelines and benchmarking standards are highly preferred.
Skills
Pharmacovigilance, SWOT analysis, regulatory review, SOP development, Risk Management Planning, data analysis, stakeholder engagement, communication, report writing, knowledge of WHO standards.