Public Health Institute (PHI)

Senior Covid-19 Vaccine Safety Surveillance Advisor

Public Health Institute (PHI)

Job Description

SUSTAINING TECHNICAL AND ANALYTIC RESOURCES FELLOWSHIP TITLE: Senior Covid-19 Vaccine Safety Surveillance Advisor HOST ORGANIZATION: Government of Uzbekistan State Services for Sanitary Epidemiological Well-Being and Public Health LOCATION: Tashkent, Uzbekistan POSITION LEVEL: Senior Technical Advisor STAR-P4-160 TRAVEL: 20% estimated travel STAR PROGRAM DESCRIPTION

Sustaining Technical and Analytic Resources (STAR) is a project of the Public Health Institute (PHI) in partnership with the University of California, San Francisco (UCSF), supported by the US Agency for International Development (USAID). STAR is a Global Health talent hub. Through fellowships, internships, and strategic partnerships, STAR supports building the capacity of diverse global health professionals and organizations at all levels to make inclusive, collaborative, and innovative contributions to global health. STAR participants collaborate in the development of systems and tools that strengthen and sustain the local and global health response. https://www.ghstar.org/ Sign up with our listserv.

ABOUT THE FELLOWSHIP

The STAR Fellowship is a global health and learning opportunity with: · Individualized, tailored support to enhance the fellow’s achievement personal and professional goals · Personalized learning plans and access to learning resources (courses, conferences, mentoring) based on fellow’s learning style and preferences.

· Access to broad professional networks to enhance peer learning and knowledge sharing.

FELLOWSHIP OPPORTUNITY DESCRIPTION

Background:

Implementing effective vaccine safety surveillance is a critical intervention for Uzbekistan’s response to its COVID-19 pandemic. The pandemic offers historically unprecedented challenges to the country’s health system. Because COVID-19 vaccines have never before been used in the country, they will require close management and monitoring. Novelty of these vaccines means that unidentified and therefore unknown adverse events during the clinical trial stages could be detected after post-marketing stage mass vaccination of populations. They would hence need to be addressed at this time. Adults, including high-priority elderly people and people with comorbid conditions, who are not normally recipients of vaccines requiring multiple doses will require special attention. Adverse events following COVID-19 immunization and adverse events of special interest associated with COVID-19 vaccination will require modified or new reporting and management procedures. Different approaches might be required for urban and rural areas and for people living in different geographic areas.

The need to address these challenges within a tight timeframe calls for maximum effort to provide the Government of Uzbekistan with needed technical resources as an order of priority. This Technical Support will be given within the parameters of approved national planning and implementation documents for COVID-19.

The 2020 COVID-19 National Strategic Preparedness and Response Plan for Health, which was produced under the technical leadership of WHO Uzbekistan and in consultation with the Ministry of Health, calls for the establishment and strengthening of the country’s vaccine safety surveillance system. Activities identified for an effective system include the following: · Guidelines and tools for planning and conducting vaccine pharmacovigilance activities developed and shared with surveillance facilities and sites.

· Vaccine safety surveillance reporting forms and procedures developed and shared.

· Passive surveillance informed by available safety information, such as risk management plans from manufacturers.

· Active surveillance plans informed by specific COVID-19 related adverse events.

· The Adverse Events Following Immunization (AEFI) Committee strengthened and trained to review vaccine safety data (for example, causality assessments of serious AEFIs, AEFI clusters, and emerging safety concerns).

· Risk management plans from manufacturers identified and COVID-19 vaccine safety data collected and shared with the Medicines Regulatory Authority.

· Stakeholder roles and responsibilities defined, and a coordinating mechanism established to exchange COVID-19 vaccine safety information. Key stakeholders include the Medicines Regulatory Authority, National Immunization Program, and WHO.

· Mechanisms to share COVID-19 vaccine data with regional and international partners identified and secured.

The National Deployment and Vaccination Plan (NDVP) for COVID-19 Vaccines in Uzbekistan (revised on 15 July 2021) describes the organization of national and subnational COVID-19 safety surveillance activities. The architecture of the country’s COVID-19 safety surveillance system depicted in the NDVP rests on the foundation of existing immunization programs and the adaptations made to them because of the pandemic. The NDVP identifies WHO as a main technical assistance provider and WHO’s 2020 COVID-19 Vaccines: Safety Surveillance Manual as a primary source of information and guidance. The NDVP describes roles and responsibilities of medical personnel; the composition of Immunization Commissions; staff training; injection safety practices; the COVID-19 immunization registration, monitoring and reporting mechanisms; Data Collection and Analysis; outbreak control and investigation; laboratory testing; supply chain management (stock, consumption and wastage information); supportive supervision; vaccine safety communication planning; and the post-introduction evaluation of COVID-19 vaccines.

Introduction:

The Senior COVID-19 Vaccine Safety Surveillance Advisor (Senior Advisor) will offer expert support to the Government of Uzbekistan’s State Services for Sanitary-Epidemiological Well-Being and Public Health (SSEW) to coordinate and implement the country’s COVID-19 vaccine safety surveillance program; identify programmatic and technical challenges; and propose practical solutions to those challenges. The Senior Advisor will provide guidance to the SSEW to determine the significance of adverse events for all COVID-19 vaccines administered in the country, assess case-level data, and gather and analyze aggregate vaccine safety surveillance data.

The Senior Advisor will provide direct technical assistance support to the SSEW and AEFI committees, while simultaneously raising their vaccine safety surveillance capacity through didactic training, on-the-job training, and staff mentorship. When called upon by the SSEW, the Senior Advisor will also provide guidance to and build the capacity of SSEW offices for vaccine safety surveillance at regional and district levels and at health facilities at all levels of Administration. The Senior Advisor will help coordinate activities between the Medicines Regulatory Authority (MRA), the National Immunization Program (NIP), other relevant government agencies, WHO, USAID (and its relevant Implementing Partners), UNICEF, U.S. Centers for Disease Control (CDC), and relevant regional and international partners.

Reporting structure:

The Senior Advisor will be based in the SSEW and take on-site direction from one of its Deputy Directors, who will serve as their Point of Contact. The Senior Advisor will provide regular, updated information and feedback to USAID at Mission and headquarters levels and collaborate with WHO, UNICEF, the US CDC, and other relevant national and international partners.

Essential Duties and Outcomes:

Strengthen SSEW’s capacity to manage and monitor the vaccine safety surveillance system in Uzbekistan:

Provide technical support to the SSEW to: · Collect, document, analyze, monitor, notify, and report on vaccine safety data and adverse events following immunization (AEFI) of all COVID-19 vaccines.

· Review and analyze risk management plans from manufacturers and communicate safety issues to SSEW subnational offices.

· Analyze signals and AEFI clusters that suggest a possible association between the administration of COVID-19 vaccines and adverse events.

· Conduct causality assessments to determine the likelihood of a causal association between an adverse event and the COVID-19 vaccine received.

· Conduct quality checks of adverse event case reports.

· Analyze case reports for indications of immunization errors such as injection maladministration, batch contamination, reconstitution mistakes, and inappropriate storage and handling.

· Investigate new outbreaks of serious adverse events (adverse events that end up in hospitalization, incapacitation, or death).

· Conduct research about unique host/genetic response factors for AEFIs based on ethnic or residential compositions in Uzbekistan.

· Train and mentor SSEW vaccine safety surveillance specialists and Immunization Commission participants at subnational and national levels.

· Track and report vaccine safety/AEFI core indicators.

· Modify existing policies, guidelines, standard operating procedures, and reporting forms on COVID-19 vaccine safety surveillance based on the national experience of Uzbekistan.

Strengthen SSEW’s capacity to coordinate the national vaccine safety surveillance response and reporting at subnational, national, and international levels and collaborate with development partners:

Provide technical support to the SSEW to facilitate collaboration and Coordination between: · The Medicines Regulatory Authority (MRA) and the National Immunization Program (NIP) (given that the MRA analyzes signal data from multiple aggregated reports and the NIP analyzes AEFI data from facilities).

· Local, district, regional, and national SSEW offices and Immunization Commissions.

· SSEW and other development partners including USAID, WHO, UNICEF, US CDC, and global stakeholders such as the WHO Global Advisory Committee on Vaccine Safety and the Uppsala Monitoring Centre.

Anticipated learning outcomes: approximate 10% time

· Cultivate mentorship skills based on the STAR GH mentorship curriculum to more effectively support and improve knowledge transfer and skills acquisition of staff, incoming fellows and interns.

· Advance leadership skills to successful support Capacity Building and knowledge sharing activities, and mentor develop junior staff.

· Apply leadership skills and technical expertise to support programmatic growth and scale up within pharmacovigilance programming.

FELLOWSHIP REQUIREMENTS

Required:

· Minimum 13 years of relevant technical experience with master's degree or a minimum of 15 years of relevant technical experience with bachelor's degree.

· An advanced degree and a specific vaccine safety surveillance/pharmacovigilance qualification.

At least seven years of experience in pharmacovigilance, vaccine research, and/or surveillance., including experience working with National Regulatory Authorities and Expanded Programs on Immunization.

· Established relationships with global vaccine safety/pharmacovigilance stakeholders.

· Experience working with community-level outbreak investigations.

· Familiarity with international AEFI database and reporting systems.

· Excellent critical thinking and analytical skills; deep knowledge of the principles of epidemiology and epidemiological statistics.

· Ability to work with both macro-level aggregated data and individual case reports.

· Experience in working with multinational and multisectoral teams.

· Strong coordination skills and the ability to work at both programmatic and technical levels and with international organizations.

· Excellent verbal communication skills, tact and diplomacy. ** · Excellent written and oral communication skills in English.

· Fluent in in spoken and written Russian.

TO APPLY:

All applicants are required to apply for this position through STAR’s online recruitment system at https://www.ghstar.org/, which allows you to store your CV/resume and separate cover letter describing your qualifications and experience, interest and familiarity with issues relating to this position, and how this position relates to your career goals is required for each application. The position will remain open until filled.**
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