International Consultant – Pharmacovigilance

The International Consultant – Pharmacovigilance will support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN), to implement the WHO Resolution and operationalize the global smart pharmacovigilance strategy. The role involves facilitating regional uptake of normative guidance, supporting pharmacovigilance system assessments, strengthening regional collaboration, and advancing the use of responsible AI in pharmacovigilance.

Responsibilities

• Facilitate regional uptake and tailoring of global normative guidance and technical tools for smart pharmacovigilance and support measurement of uptake and impact of the global smart pharmacovigilance strategy.
• Support pharmacovigilance system assessments and assist countries in addressing and implementing pharmacovigilance components of Institutional Development Plans.
• Support the establishment, maintenance and development of activities of related WHO Collaborating Centres in the Region and SEARN Regional centres of excellence.
• Support regional implementation of HQ-developed pharmacovigilance tools and protocols and contribute to ensuring relevant data are shared with HQ advisory committees.
• Participate in providing feedback to HQ on feasibility and contextualization of global pharmacovigilance metrics; coordinate and support pilots in selected countries and scale‑up.
• Strengthen regional pharmacovigilance collaboration, including information‑sharing mechanisms, reliance and work‑sharing arrangements, and joint signal and safety issues reviews with NRAs and programmes.
• Support countries in prioritizing risk‑based pharmacovigilance actions and strengthen collaboration within immunization and public health programmes.
• Advocate for the Vaccine Safety Net (VSN) and promote trustworthy communication channels.
• Contribute to the Regional activities in PIDM forums and support organization of regional PIDM activities when hosted by a Member State.
• Provide technical assistance to countries to detect and act on local signals and participate in convening regional network meetings on priority topics.
• Advance the use of responsible AI in pharmacovigilance in the context of the region.
• Participate in the conduct of surveys and landscape analysis of uptake of Smart Strategy and SEARN workplan.
• Support the coordination and project management of the related SEARN groups.
• Deliver comprehensive, timely, client and solution-oriented technical and administrative support across all budget centres, strengthening country office capacity through responsive engagement, collaboration, and accountability.
• Perform any other relevant duties assigned by supervisors.

Requirements

• An advanced university degree in pharmacy, medicine, public health, pharmacoepidemiology, pharmaceutical sciences or a related discipline.
• Specialized training in pharmacovigilance, regulatory science, epidemiology/biostatistics, data science/AI ethics, or health informatics is desirable.
• Five to ten years of relevant experience in pharmacovigilance, medicines or vaccine safety and regulatory science, including experience with signal detection/assessment and safety communication.
• Significant experience with national authorities and/or medical products manufacturing sector especially in LMICs.
• Experience with GBT benchmarking/IDP implementation is desirable.
• Familiarity with UMC/WHO tools (VigiFlow, VigiLyze, VigiMobile/MedSafety) and MedDRA/WHODrug is desirable.
• Significant experience in South-East Asia is desirable.
• Applied knowledge of pharmacovigilance methods across the product life‑cycle; AESI case definitions; causality assessment at individual and population levels; RMP/PSUR/PBRER review; benefit–risk assessment.
• Practical understanding of risk‑based prioritization, reliance/work‑sharing models, and integration of pharmacovigilance in regulatory and public‑health systems.
• Data skills including management, quality assurance, basic analytics/visualization; familiarity with ICH E2B(R3) standards and data governance principles.
• Excellent writing, facilitation, and stakeholder engagement skills; ability to develop guidance, SOPs and training.
• Computer proficiency beyond the basics, particularly office environment (Excel, Word, PowerPoint).
• Expert knowledge of English is essential.
• Expert knowledge of South-East Asian language(s) is desirable.

Skills

• Pharmacovigilance
• Regulatory Science
• Signal Detection
• Safety Communication
• Medicines Safety
• Vaccine Safety
• Pharmaco-epidemiology
• Pharmaceutical Sciences
• Epidemiology
• Biostatistics
• Data Science
• AI Ethics Frameworks
• Health Informatics
• GBT Benchmarking
• IDP Support
• UMC Tools
• VigiFlow
• VigiLyze
• VigiMobile
• MedSafety
• MedDRA
• WHODrug
• AESI Case Definitions
• Causality Assessment
• RMP Review
• PSUR Review
• PBRER Review
• Risk-Benefit Analysis
• Risk Prioritization
• Reliance Models
• Work-Sharing Models
• Pharmacovigilance Integration
• Data Management
• Data Quality Assurance
• Data Analytics
• Data Visualization
• ICH E2B(R3) Standards
• Data Governance
• Guidance Materials Development
• SOP Development
• Training Development
• Stakeholder Engagement
• Facilitation Skills
• Excel
• Word
• Power Point

Languages

English