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Research Consultant

JOB SUMMARY
Company	DKT Internati...
Industry	Not-for-profi...
Category	Science
Location	Northern Regi...
Job Status	Contractor/Co...
Salary	GHS
Education	Advanced Degr...
Experience	5 years
Job Expires	Feb 20, 2018
Contact	...

Company Profile

DKT Anglophone West Africa (AWA), is an innovative, adventurous and sustainable social marketing enterprise that improves people’s lives in Ghana, Liberia and Sierra Leone by contributing to raising modern contraceptive prevalence rate, reduce maternal mortality and provide safe quality options for HIV/AIDs prevention.

Job Description

TERMS OF REFERENCE ON POST AUTHORIZATION SAFETY STUDY OF DKT’S FAMILY PLANNING PRODUCTS

Background

According to the Directive 2010/84/EU, the new definition of a post-authorization safety study is “any study relating to an authorized medicinal product conducted with the aim of identifying, characterizing or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures”.

In as much as most ADRs are identified during clinical trials, some Adverse Events (AEs) may remain invisible or unverified until post-marketing use. PASS are ultimately the number one step of the iterative process of pharmacovigilance. They help identify, characterize or quantify an identified potential or theoretical safety hazard, confirm the safety profile of an authorized product or measure the effectiveness of the risk mitigation measure under real world and contribute to the benefit-risk evaluation of medicinal products.

Public safety is of utmost concern to DKT International Inc., Ghana and in light of this, it seeks to develop a robust pharmacovigilance system to regulate and promote public safety through drug monitoring and an evidence based scientific research to ascertain safety profile of its medicinal products

Currently, the organization is the Marketing Authorization Holder of about 4 medicinal products and as part of its efforts to promote public safety, it has taken upon itself to conduct PASS for all products being distributed by the organization. These are; Lydia postpill, Lydia Daily Oral Contraceptive pill (Lydia OCP), Lydia IUCD, Kiss and Fiesta condoms

Although side effects of the products are contained in the product leaflets, these alone are not enough as they are obtained through the clinical trials during the production stage of the products. The company therefore thought it wise to conduct PASS in the real world to ascertain both known and unknown side effects of its products

Project	Post Authorization Safety Study
Coverage	Nationwide
Funder	DKT International Inc., Ghana
RFP Release Date	26 January, 2018
Deadline for Questions	29 January,2018
Answers to Questions	To be released by 5 February, 2018
Deadline for Proposals	2 February, 2018
Contact	Gertrude Amo: procurement@dktghana.org 0302-772799

Objectives

The general objective is to know the safety profile of the company’s products among the general population in Ghana.

Specific objectives

To quantify the potential or identified risks of each product
To evaluate the risks of the products used among special populations (e.g pregnant women, specific age groups and patients with renal or hepatic impairment)
Assess patterns of drug utilization that add knowledge on the safety of the medicinal product (e.g indication, dosage, co-medication, medication errors)
Measure the effectiveness of a risk minimization activity
Evaluate the risks of a medicinal product after long term use
Provide evidence about absence of risks

Methods

This will include

Structured questionnaire
Structured interview guide

Methodology developed by consultant (s) will be reviewed by a team from DKT International. The decision is not DKT exclusive, consultants would be expected to bring forward suggestions on methodologies they will employ in the study

Output

The main body of the report should not exceed 25 pages and should include an executive summary and recommendations. Technical details should be confined to appendices, this should include the work plan of the consultant (s). Background information should only be included when it is directly relevant to the report’s analysis and conclusions.

The consultant (s) should support their analysis with relevant data and state how this has been sourced. Recommendations should also include details as to how they might be implemented

Timeframe

We anticipate a time frame of not more than 6 months starting from March, 1st 2018

Scope of work

The work is expected to be carried out nationwide under the following categories.

The northern belt which will constitute the 3 northern regions
Middle belt
Coastal part

Consultant (s)

DKT International plans to employ the services of a consultant (s) or a research firm. There should be a lead consultant who will be responsible for the execution of the research. The lead consultant will be fully responsible for managing any required team (both in terms of quality and timeliness of activities and outputs), and along with their team members, for designing the details of the research methodology, delivery of an approved final report.

Deliverables

The lead consultant is responsible for the timely submission of the following deliverables to DKT’s Senior Regulatory Affairs Manager and QPPV.

Inception Report/Tools: This will involve all inception documentations including research tools, protocols and proposals;
Ethical Clearance: Approval letter from either Noguchi Memorial Institute for Medical Research (NMIMR) or the Ghana Health Service Ethical Clearance Committee
First Draft Research Report : The first draft will be submitted within two weeks of the end of the data collection exercise;
Final Research Report The submission will include all data sets, annexes and presentations. The consultant will present three bound copies of the final report, and a CD Rom copy of the report.

The final research report will be a maximum of 25 pages including an Executive Summary. The executive summary of the evaluation report will be presented to DKT as the summary evaluation report.

Proposed Payment Terms

Payment will be made based on the proposed payment structure:

50 percent within 2 weeks of signing contract;
50 percent within 2 weeks of completion and submission of project deliverables

Technical & Financial Proposals

The technical and financial proposal should be no more than 15 pages, 12 point font and 1.5 line spacing excluding Appendixes. It should address the following areas:

Experience of firm in this area including past performance, especially as related to pharmacovigilance
Principal Investigator experience and qualifications (include CV as Appendix);
Description of other key personnel if necessary (include CVs as appendix);
Sampling strategy and methodology;
Description of proposed field work operations plan;
Quality control measures in data collection;
Data entry approach and quality assurance measures including use of incentives for participation;
Budget for the entire research;
The budget narrative must explain the assumptions behind all cost estimates including number of interviews per enumerator, number of travel days, number of field days (with due allowance for travel days). It should also explain the data entry assumptions (whether manual or direct entry using tablets for field work), as well as the time line for data collection and data entry and other items relevant to the TORs.
Ethics review experience and proposal;
Any other issues relevant to the TORs;

Structure of Financial Proposal

The financial proposal must be submitted in a separate sealed envelope from the Technical Proposal. The budget narrative must explain the assumptions behind all cost estimates including number of interviews per enumerator, number of travel days, number of field days (with due allowance for travel days). It should also explain the data entry assumptions (whether manual or direct entry using tablets for field work), as well as the time line for data collection and data entry and other items relevant to the TORs.

Required Skills or Experience

Consultant (s) must demonstrate experience and expertise in competently designing and undertaking quantitative and qualitative research methodology.
The lead consultant must possess an advanced degree (preferably PhD) in pharmacovigilance or Health Science and at least 5 years’ experience conducting research in this area.
He/she should have a solid understanding of pharmacovigilance especially in the area of PASS.
He/She should be fluent in written and spoken English.

How To Apply

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