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Purpose of consultancy
Under the supervision of the Unit Head, Medical Products Regulation and the Pharmacovigilance Team Lead in WHO headquarters (HQ), and in close collaboration with the WHO country offices in the region, the Technical Officer (Pharmacovigilance) will support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN), 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
Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. Since it was established in 1968, the WHO Programme for International Drug Monitoring (WHO PIDM) has sought to put medicines and vaccine safety at the heart of global healthcare. Published in 2025, The global smart pharmacovigilance strategy represents a comprehensive and adaptive framework that establishes a risk-based prioritization, meeting the need to address innovation and also to implement reliance mechanisms, within global multilateral cooperation mechanisms.
Deliverables
Deliverable 1: Attendance in induction meeting.
Deliverable 2: Activity plan agreed within the first month with Unit Head and HQ counterpart covering the following deliverables:
- 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 PV strategy (e.g., prioritized product lists, AESI risk registers, reliance/work‑sharing, VigiBase use, PV maturity progress).
- Support pharmacovigilance system assessments (e.g., WHO Global Benchmarking Tool – GBT) and assist countries in addressing and implementing PV components of Institutional Development Plans (IDPs).
- Support the establishment, maintenance and development of activities of related WHO Collaborating Centres in the Region and SEARN Regional centres of excellence, including through assisting centres in adapting the WHO ISoP PV curriculum , training material and coordinating the required expertise.
- Support regional implementation of HQ-developed PV tools and protocols (e.g., reporting forms: VigiMobile, VigiFlow/VigiLyze, active surveillance protocol, Background data on Adverse Events of Special Interest (AESI), Risk Management Plan (RMP) assessment templates and risk management strategies, including for the introduction of prequalified and new medicines/vaccines, and contribute to ensuring relevant data are shared with HQ advisory committees.
- Participate in providing feedback to HQ on feasibility and contextualization of global PV metrics; coordinate and support pilots in selected countries and scale‑up.
- Strengthen regional PV collaboration, including information‑sharing mechanisms, reliance and work‑sharing arrangements, and joint signal and safety issues reviews with NRAs and programmes, especially through SEARN.
- Support countries in prioritizing risk‑based PV actions and strengthen collaboration of PV within immunization and public health programmes, to reduce data silos, align case definitions, investigations and risk communication.
- Advocate for the Vaccine Safety Net (VSN) and promote trustworthy communication channels.
- Contribute to the Regional activities in PIDM forums (e.g., annual meeting) 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, including through SEARN.
- Advance the use of responsible AI in PV 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.
- To perform any other relevant duties assigned by supervisors.
- Deliver comprehensive, timely, client and solution-oriented technical and administrative support across all budget centres, proactively strengthening country office capacity through responsive engagement, collaboration, and accountability to deliver measurable results for Member States.
Deliverable 3: Six-month Progress report agreed with Unit Head and HQ counterpart
Deliverable 4: Nine-month Progress report agreed with Unit Head and HQ counterpart
Deliverable 5: Summary activity report agreed with Unit Head and HQ counterpart
Qualifications, experience, skills and languages
Educational Qualifications:
Essential: An advanced university degree in pharmacy, medicine, public health, pharmacoepidemiology, pharmaceutical sciences or a related discipline.
Desirable: Specialized training in pharmacovigilance, regulatory science, epidemiology/biostatistics, data science/AI ethics, or health informatics.
Experience
Essential:
- Five to ten years of relevant experience in PV/ 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.
Desirable:
- Experience with GBT benchmarking/IDP implementation,; familiarity with UMC/WHO tools (VigiFlow, VigiLyze, VigiMobile/MedSafety) and MedDRA/WHODrug.
- Significant experience in South-East Asia.
Skills/Knowledge:
Essential:
- Applied knowledge of PV 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 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.
- Computer proficiency beyond the basics, particularly office environment (Excel, Word, PowerPoint).
Languages and level required (Basic/Intermediate/Expert):
Essential: Expert knowledge of English
Desirable: Expert knowledge of South-East Asian language(s).
Location
On site: SEARO, New Delhi
Travel
As required by the activities as agreed by Unit Head and Director.
Remuneration and budget (travel costs are excluded)
Remuneration - Pay Band Level B - USD 77,000 (depending on the experience and the nature of work)
Living expenses - Travel expenses and per diem will be covered as per WHO rules applicable to consultants for approved official travel during the contract period: currency and rate
Expected duration of contract - 11 months
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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