Consultants Pharmacovigilance Systems Strengthening

The consultant will conduct a detailed landscape and SWOT analysis of vigilance systems within the Botswana Medicines Regulatory Authority (BoMRA) and related stakeholders. The role includes reviewing guidelines, SOPs, regulatory actions aligned with WHO standards, and providing guidance on communication and training materials to strengthen pharmacovigilance systems.

Responsibilities

• Conduct a detailed landscape and SWOT analysis of vigilance systems within BoMRA and related stakeholders in Botswana.
• Review guidelines, Standard Operating Procedures (SOPs), working tools, and regulatory actions aligned with WHO Global benchmarking standards.
• Evaluate Risk Management Planning (RMP) and related documents, safety communication and vigilance data publication, vigilance documents during Good Vigilance Inspections, and implementation of IDPs at Adverse Drug Reaction Monitoring Centres.
• Provide guidance on communication to BoMRA stakeholders to enhance understanding and compliance with regulations and guidelines.
• Prepare monthly progress reports summarizing activities, progress against milestones, challenges, mitigation actions, and recommendations.
• Deliver a comprehensive end-of-activity report on vigilance systems and recommendations for strengthening existing systems.
• Achieve >95% completion of GBT implementation by March 2027.
• Review and recommend improvements to training materials including presentations, handouts, and session summaries for safety surveillance and causality assessment.
• Provide recommendations for sustaining and accelerating progress in pharmacovigilance systems strengthening.

Requirements

• Master's degree in pharmacy, medicine, public health, or related field.
• Minimum of 3 years of experience in pharmacovigilance, drug safety, or regulatory affairs.
• Experience conducting system analyses and evaluations in pharmacovigilance or related regulatory environments.
• Knowledge of WHO Global benchmarking standards and pharmacovigilance guidelines.
• Ability to review and evaluate Risk Management Planning (RMP) documents and safety communication materials.
• Experience in developing and reviewing training materials for safety surveillance and causality assessment.
• Strong report writing skills including preparation of progress and comprehensive end-of-activity reports.
• Ability to provide guidance on communication strategies to stakeholders to enhance compliance with regulations and guidelines.

Skills

• Pharmacovigilance
• Drug Safety
• Legal Regulatory Affairs
• Systems Analysis
• Equipment Evaluation
• WHO Global Benchmarking
• Risk Management Planning
• Safety Communication
• Training Material Development
• Causality Assessment
• Report Writing
• Progress Reporting
• End-of-Activity Reporting
• Communication Strategy
• Stakeholder Engagement

Languages

English