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Purpose of consultancy
Under the supervision of the Unit Head, Medical Products Regulation and in close collaboration with WHO headquarters (HQ REG/MSC Team Lead), and country offices, the Technical Officer (Market Surveillance and Control) will Support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN), in preventing, detecting, and responding to substandard and falsified (SF) medical products, including In Vitro Diagnostics and other medical devices, through strengthened GSMS (Global Surveillance and Monitoring System) reporting, incident management, risk communication, risk-based post market surveillance activities, promoting compliance with GxPs requirements, and Quality Control Laboratory (QCL) enablement.
Background
In accordance with the Constitution of the World Health Organization and a number of World Health Assembly resolutions relating to the quality, safety and efficacy of medicines, WHA 41.16 (1988) requested WHO to ‘initiate programmes for the prevention and detection of export, import and smuggling of falsely labelled, spurious and counterfeited or substandard pharmaceutical preparations, and to co-operate with the Secretary General of the UN in case provisions of the International Drug Treaties are violated’. The WHO continues to assist Member States in strengthening regulatory capacity to tackle substandard and falsified (SF) medical products and does so through focusing on prevention, detection and response.
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:
1. Technical support to Member States
- Provide technical assistance in developing and implementing National Action Plans related to SF medical products
- Support the development and implementation by NRA of incident reports
- Support the development and implementation by NRA of risk-based inspections and collaboration between NRAs to optimize GMP inspections
- Support the delivery of technical assistance to national quality control laboratories (NQCLs), including through on-site visits, twinning programmes, and peer-learning initiatives.
- Enable NRAs to publish IVD field safety notices (FSNs) and Field safety corrective actions (FSCAs) using searchable, structured formats aligned with International Medical Device Regulators Forum (IMDRF) datasets.
- Contribute to the planning, monitoring, and evaluation of SF risk-based post-market surveillance activities and laboratory capacity-strengthening efforts towards WHO Listed Quality Control (WLQCL) program.
2. Regional network and partnership coordination
- Support the development of collaboration with regional regulatory authorities and laboratory networks, including through SEARN.
- Support the coordination and project management of the related SEARN groups.
- Coordinate day‑to‑day GSMS focal‑point (FP) engagement, onboarding, mentoring, and regional/subregional FP meetings.
- Contribute to supporting joint activities with partners in official relations with WHO, including UNODC, WCO, WOAH, Interpol, and academic laboratories.
3. Incident reporting and analytics
- Coordinate regional reporting to GSMS and SEARN, and provide support to NRAs and WHO in incident management related to SF medical products.
- Support uploads, curation and validation of reports, and local media/signal scanning to improve data quality and contextualized risk assessments.
- Produce localized threat assessments and thematic briefs for national, regional authorities and networks and the HQ team.
4. Risk communication
- Adapt and disseminate global risk communication tools to regional contexts; support country‑level risk communication plans and provide surge support during incidents.
5. Training, Capacity Building, and Knowledge Dissemination
- Organize and contribute to regional training sessions using the SF toolkit and other relevant materials, delivered through regional centres of excellence and collaborating centres.
- Contribute to the development, dissemination, and evaluation of training materials, guidance tools, and technical resources for SF and laboratory strengthening activities.
- Monitor and evaluate the delivery and impact of training programmes, ensuring alignment with regional priorities and WHO standards.
- 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 developing curriculum, training material and coordinating the required expertise.
6. Reporting and Coordination
- Provide input into regional planning and reporting processes, ensuring timely and accurate documentation of activities and outcomes.
- Submit quarterly KPI updates, contribute to After‑Action Reviews (AARs), and support biennium reporting.
7. Other tasks:
- To perform any other relevant duties assigned by supervisors.
- Deliver comprehensive, timely, client and solution-oriented technical and administrative support across all budget centers, proactively strengthening country office capacity through responsive engagement, collaboration, and accountability to deliver measurable results for Member States.
Deliverable 3: 6 month Progress report agreed with Unit Head and HQ counterpart
Deliverable 4: 9 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: Advanced university degree in pharmacy, chemistry, biochemistry, microbiology, or a related health or life sciences field.
Experience
Essential: Five to ten years of relevant professional experience in medical product market surveillance, pharmaceutical quality assurance, including either demonstrated experience in strengthening regulatory / laboratory systems and regulatory inspections experience, or working with medical products manufacturing industry and having significant experience in setting up active market surveillance system for manufacturers and GMP.
Desirable: Experience with post‑market surveillance for IVDs/devices; incident coding and data systems; laboratory QA for for‑cause testing. Significant experience in South-East Asia.
Skills/Knowledge:
Essential: Strong analytical and communication skills; IT/data literacy (spreadsheets, dashboards, analytics; Risk‑communication competencies; stakeholder engagement.
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.
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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