International Consultant - Pharmacovigilance

Organizational Context

The World Health Organization (WHO) is dedicated to improving global health. The SE/HSD Department of Health Systems Development focuses on strengthening health systems. This role supports the WHO Programme for International Drug Monitoring (WHO PIDM) and its global smart pharmacovigilance strategy, aiming to enhance medicine and vaccine safety worldwide.

Job Purpose

This consultancy aims to support Member States and regional networks, particularly the South-East Asia Regulatory Network (SEARN), in implementing the WHO Resolution on pharmacovigilance and operationalizing the global smart pharmacovigilance strategy. The role will focus on risk-based prioritization, reliance and work-sharing mechanisms, integration into regulatory systems, and strengthening safety communication. The consultant will provide technical assistance, facilitate uptake of guidance and tools, support system assessments, and foster regional collaboration to improve pharmacovigilance practices and ensure the safety of medicines and vaccines across the region.

Responsibilities

Key responsibilities include facilitating the regional adoption and adaptation of global pharmacovigilance guidance and tools, supporting the measurement of the smart PV strategy's impact, and assisting countries with pharmacovigilance system assessments and the implementation of Institutional Development Plans. The role involves supporting WHO Collaborating Centres and SEARN regional centers of excellence, aiding in the implementation of WHO-developed PV tools and protocols, and contributing to data sharing with HQ advisory committees. Additionally, the consultant will provide feedback on global PV metrics, coordinate pilot projects, strengthen regional collaboration through information sharing and joint reviews, and advocate for the Vaccine Safety Net. The role also includes providing technical assistance for local signal detection, supporting regional network meetings, advancing the use of AI in PV, conducting landscape analyses, and coordinating SEARN groups.

Work Experience

Essential experience includes five to ten years in pharmacovigilance, medicine/vaccine safety, and regulatory science, with expertise in signal detection, assessment, and safety communication. Significant experience with national authorities and/or the medical products manufacturing sector, particularly in low- and middle-income countries, is required. Desirable experience includes familiarity with WHO Global Benchmarking Tool (GBT) and Institutional Development Plan (IDP) implementation, WHO tools (VigiFlow, VigiLyze, VigiMobile/MedSafety), MedDRA/WHODrug, and specific experience in South-East Asia.

Skills

Essential skills include applied knowledge of pharmacovigilance methods, adverse event of special interest (AESI) case definitions, causality assessment, risk management plan (RMP)/PSUR/PBRER review, and benefit-risk assessment. Practical understanding of risk-based prioritization, reliance/work-sharing models, and PV integration into health systems is crucial. Data management, quality assurance, basic analytics/visualization, and familiarity with ICH E2B(R3) standards are required. Excellent writing, facilitation, and stakeholder engagement skills, along with proficiency in office software (Excel, Word, PowerPoint), are necessary. Expert knowledge of English is essential; expert knowledge of South-East Asian languages is desirable.

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