Consultancy to conduct data analysis and develop the report for the Dolutegravir Cohort Event Monitoring survey

Purpose of the Consultancy:

The United Republic of Tanzania introduced dolutegravir based regimens in 2019. As part of standard quality of care, the Zanzibar Food and Drug Authority (ZFDA) and Zanzibar Integrated HIV, Hepatitis, TB, and Leprosy (ZIHHTLP) of Ministry of Health, conducted a cohort event monitoring survey from 2022-2023. Data was collected from the 14 Care and Treatment centre (CTCs) and PLHIV on ART followed up for over 9 months. Data has been entered into the database for analysis. The results from this survey will indicate any adverse events noted over the period of the survey and guide MOH in further management of PLHIV on DTG based regimens. As such WHO would want to support the ZFDA and ZIHHTLP to analyzed and interpret the data for use in decision making and programming.

2.Work to be performed.

Under the general coordination of the WHO Country Representative, Cluster Lead CND, ZFDA Focal Point and ZIHHTLP Manager’s supervision, the consultant will conduct data analysis, interpretation and report writing for the CEM survey. The selected candidate will perform the following tasks working closely with CEM Committee:

•Review the data entered and clean the data and ensure that all the data fields are completed.

•Develop a data analysis plan and analyze the data and share data tables with ZFDA and ZIHHTLP for their approval.

•Develop the report for the CEM survey guided by the objectives of the protocol and the CEM Committee

•Share the report with ZFDA, ZIHHTLP and the CEM committee for their review and in cooperate their comments.

•Finalize the CEM report until approval by ZFDA and ZIHHTLP

•Develop the draft manuscript for the CEM and submit for review by CEM committee.

Deliverables

Key deliverables from this assignment will include:

Final Report for the Cohort Event Monitoring survey for Zanzibar

Draft Manuscript for the CEM survey

3.Specific Requirements

LANGUAGE:

English Language is required

Read:Expert knowledge

Write:Expert knowledge

Speak:Expert knowledge

EDUCATION:

Desired: Medical Doctor or Pharmacist with a Master’s degree in Public Health, Epidemiology, Regulatory Sciences, or a related field from an accredited/ recognized institute.

EXPERIENCE:

Essential:

•The Consultant must have at least 5-10 years’ experience in pharmacovigilance

•Relevant work experience and comprehensive knowledge of pharmacovigilance including coordinating and leading such studies.

•Demonstrable experience in conducting clinical studies, preferably in Cohort Event Monitoring.

•In-depth knowledge of the principles, practices, methods, and techniques of Cohort Event Monitoring for safety surveillance.

•Well-versed in regulatory sciences and practices related to medical studies including MedDRA terminologies.

•Experience and proficiency in statistical analysis including multivariant analysis.

•Excellent report writing skills including experience in developing manuscripts supported by publications one has contributed to.

•Analytical and documentation skills, presentation of reports

•Fluent in spoken and written English

WHO Competencies REQUIRED

1.Communicating in a credible and effective way

2.Fostering integration and teamwork

3.Producing Results

4.Building and promoting partnerships across the organization and beyond

5.Respecting and promoting individual and cultural differences.

Other Skills (e.g. IT):

•Good command of Computer Application Systems

4.ASSIGNMENT

This consultancy is at NOC Level

5.TIMELINE AND REPORTING

Duration

•The duration of the consultancy is 30 days. The consultancy is expected to begin mid-April 2024 and complete assignment within 30 days.

Proprietary Rights

•Outputs delivered under this consultancy contract will remain the property of the ZFDA, Ministry of Health, Zanzibar and WHO