International Consultant - Pharmacovigilance in the WHO Western Pacific Region

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Qualifications

Purpose of consultancy 

The Consultant will support Member States to implement the WHO Resolution on and to operationalize the global smart pharmacovigilance strategy, including risk-based prioritization, reliance/work-sharing, integration in regulatory systems, and strengthened safety communication.

Background  

The WHO Western Pacific Region is advancing a system‑wide, risk‑based approach to pharmacovigilance (PV) through implementation of the WHO Smart Pharmacovigilance (Smart PV) Strategy. This includes strengthening national PV systems, improving regulatory and programmatic coordination, expanding the use of WHO normative tools (e.g. VigiFlow/VigiLyze, Model RMP Assessment Tools, AESI protocols), and enhancing regional collaboration for signal detection, assessment, and communication related to the safety of medicines and vaccines. 

This consultancy will provide technical coordination and hands‑on support to Member States, WHO Country Offices, WHO Collaborating Centres, and WHO Programme for International Drug Monitoring (PIDM), with a strong focus on Smart PV implementation, capacity building, regulatory risk management, targeted PV studies, and regional and global engagement

Deliverables

The Consultant is expected to complete the following outputs and deliverables:

Output 1: Regional implementation and monitoring of the Smart Pharmacovigilance Strategy strengthened.
Deliverable 1.1 Conduct landscape analysis to assess uptake and implementation of the WHO Smart Pharmacovigilance Strategy across Member States.
Deliverable 1.2 Facilitate regional uptake of normative guidance and technical tools for Smart Pharmacovigilance, including prioritized product lists, AESI risk registers, reliance/work‑sharing approaches, use of VigiBase and Vigi-tools, and PV maturity measures.

Output 2: National pharmacovigilance systems strengthened through assessments, risk‑based approaches, and regulatory tools.
Deliverable 2.1 Assist countries in addressing and implementing WHO Global Benchmarking Tool (GBT) Vigilance (VL) indicator-related actions within Institutional Development Plans (IDPs). 
Deliverable 2.2 Support strengthening integration of PV within immunization programmes and other public health programmes, to reduce data silos and align case definitions, investigation practices and risk communication. 

Output 3: Roll-out of WHO Model Risk Management Plan (RMP) Assessment Tools supported. 
Deliverable 3.1 Support the regional roll-out of the WHO Model Risk Management Plan (RMP) Assessment Tools and assist NRAs in applying the tools during regulatory review of medicines and vaccines, including reliance-based review opportunities.
Deliverable 3.2 Support planning and facilitation of a regional workshop and/or virtual training activities on RMP assessment, risk-based pharmacovigilance and regulatory risk communication.

Output 4: Medicines safety surveillance study implemented and supported
Deliverable 4.1 Support preparation for implementation of drug utilization study on sodium valproate in a selected country in the Region.

Qualifications, experience, skills and languages

Educational Qualifications: 
Essential: Advanced degree (A Master’s degree or higher) in pharmacy, chemistry, biochemistry, microbiology, or a related health or life sciences field from a recognized university. 
Desirable: Specialized training in pharmacovigilance, regulatory science, epidemiology/biostatistics, data science/AI ethics, or health informatics.

Experience:
Essential: At least five years of relevant experience in pharmacovigilance/regulatory science/medicines or vaccine safety, including experience with signal detection/assessment and safety communication; experience supporting national authorities or programmes in LMICs at national and international level.
Desirable: Experience with reliance/work-sharing, GBT benchmarking/IDP implementation, active surveillance; familiarity with UMC/WHO tools (VigiFlow, VigiLyze, VigiMobile/MedSafety) and MedDRA/WHODrug.

Skills/Knowledge: 
Essential:
- Applied knowledge of PV methods across the product life cycle; AESI case definitions; causality assessment; RMP/PSUR/PBRER review; benefit–risk assessment.
- Practical understanding of risk-based prioritization, reliance/work-sharing models, and integration of PV in regulatory and public health systems.
- Data skills: 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.

Languages and level required (Basic/Intermediate/Expert):
Essential: Expert knowledge of English (read, write, speak)
Desirable: Basic knowledge of other languages spoken within the Western Pacific Region

Location  

On site: WHO Regional Office for the Western Pacific – Manila, Philippines

Remuneration and budget
 

• Remuneration: USD 8,000 per month (Payband level B) 
• Living Expenses: USD 2,100 per month
• Expected duration: 6 months
  
   

Travel

The consultant may need to travel to selected countries in the Western Pacific Region. 

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
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