The purpose of this consultancy is to assist the WHO Regional Office for the Western Pacific, Division of Health Systems and Services, Team of Essential Medicines and Health Technologies in strengthening Member States’ post-market quality surveillance and safety vigilance of medical products.

Ensuring universal access to safe, effective, high-quality, and affordable medical products is paramount for achieving comprehensive healthcare coverage. The persistent global challenge of securing the availability of quality-assured medical products has recently been underscored by incidents of ethylene glycol (EG)/diethylene glycol (DEG) contamination in syrup medicines reported worldwide. This has brought to light an urgent need to raise awareness and take decisive actions to eliminate substandard and falsified (SF) medical products from the market. In response to this critical issue, the World Health Organization (WHO) issued its inaugural Medical Product Alert in September 2022, and similar cases have surfaced in various countries globally. Resource-limited nations are seeking the assistance of WHO and its partners to bolster efforts in detecting, preventing, and managing substandard and falsified medical products. Addressing this challenge is essential for creating a healthcare landscape where all individuals can access reliable and safe medical treatments. Furthermore, enhancing the vigilance system stands as a pivotal component in ensuring the safety and secure usage of medical products among patients and populations. Ongoing challenges encompass issues such as under-reporting of an adverse event (AE), delays in timely investigations, incomplete causality assessments, and insufficient resources. In collaboration with partners, the World Health Organization (WHO) is steadfast in its commitment to supporting diverse strategies that focus on establishing or reinforcing the vigilance system, particularly in low and middle-income countries.

By working closely with the WHO country offices in the Western Pacific Region, relevant units in the Headquarters and WPRO, and other external partners, the consultant will be responsible for providing high-quality work to achieve the following outputs:

Output 1: Strengthen the capacity of the national stakeholders in coordination with and guidance from the respective WHO country office to address incidents of SFMP and AE

1.1 Identify, update, and maintain the collaboration networks with the national counterpart in addressing SFMP and AE incidents

1.2  Collate information and address requests such as testing and surveillance from the national counterparts

1.3  Draft risk communication material and liaise with communication experts within the division of DHS and WPRO

Output 2: Strengthen the capacity of the national system in coordination with and guidance from the respective WHO country office to improve the management of SFMP and AE

2.1 Collect and facilitate requests from the relevant governmental agencies for technical assistance in line with NRA benchmarking and institutional development plan

2.2 Review NRA’s training plan, design the training program, and facilitate training

2.3 Update regional plan for country prioritization and coordination

Output 3: Strengthen regional and global coordination and monitor and evaluate the performance of the national system in coordination with and guidance from the respective WHO country office to improve the management of SFMP and AE

3.1 Participate in global coordination calls and provide inputs to the calls

3.2 Update partner engagement in the area of market surveillance and vigilance

3.3 Complete other tasks as identified by the responsible officer and upper-level management

Method(s) to carry out the activity

Support implementation of the relevant post-market quality surveillance and safety vigilance of medical products

Support process documentation, such as drafting notes for the record, progress reports, etc.

Conduct literature search, gather data, and conduct relevant analysis, draft technical briefs, presentations, and talking points

Coordinate internal and external stakeholders and facilitate discussions.

Maintain regular communication and engagement through emails, virtual meetings, and face-to-face meetings

Provide technical support under the supervision of the responsible officer.

Essential : University degree in pharmaceutical sciences public health or relevant health-related field

Desirable: Postgraduate degree in regulatory sciences.

Essential :  Minimum five years of experience in market surveillance and vigilance. Demonstrated experience in government service, and strong knowledge about the WHO rapid alert system for SF MPs and WHO programme on international drug monitoring.

Desirable : Work experience with the governments of resource-limited countries, WHO and UN organizations

A thorough knowledge of detection, prevention and response to SF MP incidents and AE incidents

Ability to lead policy and practice implementation work within an institutional development plan that is established through the NRA benchmarking process

Excellent interpersonal skills with the demonstrated ability to work effectively with government officials as well as with national and international organizations

Demonstrated ability to build partnerships and work in multicultural and multidisciplinary settings

Good communication skills and a teamwork spirit

Strong writing skills and good attention to detail

Persistence in follow-up, tact, and diplomacy in working with diverse stakeholders

Expert knowledge of English

The contractual partner will be assigned to work offsite.

Pending clearance, the individual consultant will be travelling to selected countries for benchmarking assessment and capacity-building training

a. Remuneration  – Band level B, USD 7,000/month

b. Expected duration of contract – 11 months, 1 April 2024 to 28 February 2025

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