International Consultant - Pharmacovigilance Systems Strengthening

About the role

The World Health Organization (WHO) is engaging an external consultant for a 3-month assignment in Gaborone, Botswana, to accelerate the implementation of Pharmacovigilance Improvement Plans (PV IDPs) so that the Botswana Medicines Regulatory Authority (BoMRA) can reach ML3 for its vigilance functions. The consultant works on site at the BoMRA head office and travels to selected sites for audits and inspections.

Key responsibilities

• Conduct a detailed landscape and SWOT analysis of vigilance systems within BoMRA and related stakeholders.
• Review guidelines, SOPs, assessment tools and GBT evidence, and give guidance needed to meet the identified IDPs.
• Integrate GBT IDP implementation to promote compliance by industry, public health entities and national regulators.
• Review RMP documents, safety communication and vigilance data publication, and the implementation of IDPs at Adverse Drug Reaction Monitoring Centres against the Field Visit Manual.
• Advise BoMRA stakeholders on how to improve understanding and compliance with regulations and guidelines.
• Produce monthly progress reports and a final report on vigilance systems, with recommendations for strengthening them.
• Review training materials (presentations, handouts, summaries) for safety surveillance and causality assessment, and recommend how to sustain progress.
• Develop a GBT evidence review plan with BoMRA, facilitate meetings and logistics, and maintain confidentiality.

Required profile

• Advanced degree in pharmacy, public health, regulatory science or a related field.
• Essential: experience in a medicines regulatory authority and more than 5 years in pharmacovigilance, vaccine safety, benefit-risk aggregated report review and risk management planning focused on risk minimisation.
• Desirable: experience with WHO Global Benchmarking Tools and/or ICH/EMA guidelines.
• Fluent in spoken and written English.

Required skills

• Expert knowledge of pharmacovigilance, vaccine safety and medicine risk management review.
• Knowledge of WHO Global Benchmarking Tools and ICH/EMA guidelines (desirable).

Remuneration follows WHO policy guidelines; travel is arranged by WHO, and full medical clearance is required if travel is involved.