International Consultant - Pharmacovigilance Systems Strengthening

Job Posting Organization:
The job posting organization is the World Health Organization (WHO), which was established in 194

• WHO's mission is to promote health, keep the world safe, and serve vulnerable populations. It operates in over 150 countries and has a workforce of more than 7,000 employees. WHO focuses on global health issues, providing leadership on international public health, shaping the research agenda, setting norms and standards, and monitoring and assessing health trends.

Job Overview:
The position of International Consultant for Pharmacovigilance Systems Strengthening is aimed at accelerating the implementation of Pharmacovigilance Improvement Development Plans (PV IDPs) to achieve a maturity level 3 (ML3) for vigilance functions. The consultant will be responsible for conducting a comprehensive baseline assessment of the vigilance systems in Botswana, reviewing existing guidelines and standard operating procedures, and providing essential guidance for fulfilling the identified IDPs. The consultant will also integrate the implementation of GBT IDPs to ensure compliance by industry and public health entities with national regulatory requirements. This role requires a deep understanding of pharmacovigilance systems and the ability to work collaboratively with various stakeholders to enhance the safety and efficacy of medicines in Botswana.

Duties and Responsibilities:
The consultant will be tasked with several key responsibilities, including: conducting a detailed landscape and SWOT analysis of vigilance systems within the Botswana Medicines Regulatory Authority (BoMRA) and related stakeholders; reviewing guidelines, SOPs, and regulatory actions to align with WHO Global benchmarking standards; evaluating Risk Management Planning (RMP) documents and safety communication publications; providing guidance on communication strategies to enhance understanding and compliance among BoMRA stakeholders; and delivering monthly progress reports summarizing activities, progress against IDP milestones, challenges encountered, and recommendations for future actions. Additionally, the consultant will be responsible for ensuring that GBT implementation status reaches over 95% completion by March 2027 and reviewing training materials for safety surveillance and causality assessment.

Required Qualifications:
The position requires an advanced degree in pharmacy, public health, regulatory science, or a related field. Essential qualifications include significant experience working within a medicine regulatory authority or agency, with a minimum of 5 years of relevant work experience in pharmacovigilance, vaccine safety, and risk management planning. Desirable qualifications include familiarity with WHO Global Benchmarking Tools and/or ICH/EMA guidelines. The consultant should possess expert knowledge in pharmacovigilance, vaccine safety, and medicine risk management review.

Educational Background:
Candidates must hold an advanced degree in pharmacy, public health, regulatory science, or a related field. This educational background is crucial for understanding the complexities of pharmacovigilance systems and regulatory requirements.

Experience:
The consultant is expected to have at least 5 years of relevant work experience in pharmacovigilance, particularly within a regulatory authority or agency. This experience should encompass areas such as vaccine safety, benefit-risk aggregated report review, and risk management planning, with a focus on implementing risk minimization measures. Experience with WHO Global Benchmarking Tools and ICH/EMA guidelines is considered an asset.

Languages:
Fluency in English, both spoken and written, is mandatory for this position. Proficiency in additional languages may be beneficial but is not required.

Additional Notes:
The consultancy is expected to be conducted on-site at the Botswana Medicines Regulatory Authority Head Office in Gaborone, with potential off-site audit and inspection visits to selected Adverse Drug Reaction Monitoring Centres (AMCs) and health facilities across Botswana. The contract duration is set for 3 months, starting from January 11, 2027, and ending on April 9, 202

• The consultant will report to Dr. Parthasarathi Gurumurthy and Mr. Lebogang Koitsiwe at BoMRA, with overall oversight from Dr. Fabian Ndenzako, WHO Representative. Travel within Botswana will be organized as per the workplan, and all travel arrangements will be managed by WHO, with full medical clearance required for travel.