Roster of Consultants – Incidents and substandard/falsified medical products

Purpose of consultancy

To contribute to the improved handling of Incidents and substandard/falsified medical products (ISF) through market surveillance, development and implementation of structured reporting systems and providing well researched and analysed information and expert recommendations on policies.

Background

Recognizing that SF medical products are an unacceptable threat to public health which undermine international public health investments and threaten the delivery of the sustainable development goals, WHO and Member States have established a two-pronged approach to tackle the issue: the Member State Mechanism and the implementation of a global surveillance and monitoring system (GSMS) for SF medical products. Both of these areas of work fall under the responsibility of the Incidents, Substandard/Falsified Medical Products Team.

The management of the GSMS as well as supporting development and implementation of structured reporting systems from all regions are key responsibilities of the team. The GSMS is designed to significantly improve the quantity and quality of available data worldwide, and use this validated evidence base to provide technical support and deploy bespoke solutions at the request of Member States.

The ISF team also provides support to strengthen the capacity of Member States and national medicines regulatory agencies to prevent, detect and respond to SF medical products through the development of tools, delivery of training, instigating research, providing technical assistance and gathering validated data to enable evidence-based policy, processes and procedures. This includes conducting and reporting on risk-based market surveillance within countries and across regions.

The WHO Regulation and Prequalification Department (RPQ) has developed a common Information Management and Technology (IMT) system, named “ePQS”. Following successful migration of post market quality surveillance data from legacy systems of the ISF team, WHO intends to make the ePQS available for Member States to store, retrieve, analyse and share, as necessary, their own surveillance data.

Deliverables:

• Output 1: Contribute to improving the quantity and quality of data in the GSMS as well as improving the ISF Team’s response time to reported incidents through supporting the receipt, recording, acknowledgement, assessment, follow up and proposing recommendations for interventions to reports of information identifying SF medical products.
  • Deliverable 1.1: Incident Report, through the review of incoming information identifying incidents of SF medical products, Medical Product Alerts or Medical Product Recall Notifications within the timelines stipulated in the ISF team quality system.
  • Deliverable 1.2: Recommendation report, by identifying information gaps and engaging with reporters to obtain necessary details and provide written advice to the reporter or the relevant Member States in order to close incident within timelines.
  • Deliverable 1.3: Updated GSMS database, updating with new reports of SF medical products by accurately inputting data and reviewing records to ensure consistency and quality within the timelines stipulated in the ISF team quality system.
  • Deliverable 1.4: Research Summary, conduct ad-hoc research on issues related to SF medical Products (e.g., literature review, media monitoring, landscape analysis, stakeholder mapping).

• Output 2: Contribute to the updated surveillance report in ePQS, provide technical support to the ISF team and Member States as well as access risk-based post market quality surveillance data in the ePQS.
  • Deliverable 2.1: National regulatory authority reviewed database, timely review of country data identifying information gaps, accuracy, consistency and quality.
  • Deliverable 2.2: Strategic reports; contribute to ISF team and Member States’ transforming migrated PMS data into reports that may be used to inform policy and actions to prevent, detect and respond to SF medical products.

Qualifications, experience, skills and languages.

Educational Qualifications:

Essential:

• Advanced degree in Pharmacy, Biomedical, Health Sciences, Public Health or a related field.

Desirable:

• Master's degree in Health Sciences or Regulatory Affairs or related fields.

Experience

Essential:

• Over ten years of relevant experience in the pharmaceutical, life sciences, or other health-related fields.
• Previous hands-on experience as a regulator or related experience in handling SF incidents, marketing or surveillance requirements for stringent regulatory systems or WHO prequalification.
• Proven experience in conducting timely and accurate research, gathering, collating and publication of scientific information on SF medical products .

Desirable:

• Experience in development, manufacture, and marketing of medical products in various markets especially low- to middle-income countries.
• Working experience in fulfilling WHO requirements or similar stringent authority for production, prequalification, quality assurance and surveillance of pharmaceuticals.

Skills/knowledge

Essential:

• Good knowledge of medical product data collection, management, and analyses.
• Strong technical knowledge in medical product quality assurance.
• Strong technical knowledge in WHO and other internationally recognized quality assurance standards and health product regulations.
• Good communication and interpersonal skills, with the ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders.
• Strong methodological and analytical skills, with the ability to conduct research, identify and analyze literature relevant to the programme area.
• Good planning and organizational skills, attention to detail and the ability to multi-task and work under pressure.
• Strong IT skills: Word, Excel, presentation software, databases and web navigators.

Languages required:

Essential:

• Expert knowledge of English.

Desirable:

• Working knowledge of another WHO official language.

Location

Off-site - Home based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C-USD 10,000 – 12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

Contract duration varies from 3 months to 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.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• 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 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 final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever 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.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html

For roster VNs:

The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.