International Consultant - Pharmacovigilance in the WHO Western Pacific Region

..

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.
•    For information on WHO's operations please visit: http://www.who.int.
•    The WHO is committed to creating a diverse and inclusive environment of mutual respect. The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics. 
The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs. 
Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to  reasonableaccommodation@who.int 
•    An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter (https://www.who.int/about/who-we-are/our-values) into practice.
•    WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of short-listed candidates.
•    WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
•    Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. 
•    WHO shall have no responsibility for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
•    Please note that WHO’s contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.
•    In case the recruitment website does not display properly, please retry by: (i) checking that you have the latest version of the browser installed (Chrome, Edge or Firefox); (ii) clearing your browser history and opening the site in a new browser (not a new tab within the same browser); or (iii) retry accessing the website using Mozilla Firefox browser or using another device. Click the link for detailed guidance on completing job applications: Instructions for candidates.