Job ID: 13-10775
Group/Office: PDG (Program Delivery Group)
Dept/Unit: PDGGEN - Program Delivery Group
Project/Program: A607 - Nigeria Global Fund RSSH
Reports To: DG NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap N1 Laws of the Federation of Nigeria 2004 as amended empowers the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement and sale of food, drugs, cosmetics, medical devices, packaged water, chemicals and detergents.
Medicinal products must also comply with the provisions of:
- Drugs and Related Products (Registration etc) Act 1999 (now Act Cap F33 Laws of the Federation of Nigeria 2004)”
- Counterfeit and Fake Drug and Unwholesome Act
This mandate requires NAFDAC to ensure the quality, safety, efficacy and wholesomeness of all regulated products, hence Pharmacovigilance. In ensuring quality and safety of medicines, the Agency shall have the following functions and powers as stipulated in part II section 5 of the NAFDAC Act:
- Pronounce on the quality and safety of food, medicines, cosmetics, medical devices, bottled water and chemicals after appropriate analysis.
- Advise federal, state and local governments, the private sector and other interested bodies regarding the quality, safety and regulatory provisions,
- Undertake and coordinate research programs on the storage, adulteration, distribution and rational use of food, medicines, cosmetics, medical devices, etc.
In discharging this mandate, quality and safety monitoring of medicines becomes expedient hence pharmacovigilance for the detection, understanding, assessment and prevention of adverse drug reactions and other medicine related problems. The first edition of the Nigerian National Pharmacovigilance Policy and Implementation Framework was developed in 2012, hence the need for a review and update after five years of existence and implementation.
- NAFDAC in collaboration with Management Sciences for Health (MSH) under the Global Fund (GF) Resilient and Sustainable Systems for Health (RSSH) grant is seeking the services of a consultant/expert to drive the multi-stakeholder review of the “Nigerian National Pharmacovigilance Policy and Implementation Framework 2012” in line with global best practices.
Scope of Work:
- The consultant/expert will report to the Director-General (NAFDAC) while closely liaising with the Director Pharmacovigilance & Post-Marketing Surveillance at NAFDAC with support from MSH under the GF-RSSH grant for Nigeria.
The successful consultant/expert is expected to:
- Conduct a situational analysis while appraising the pharmacovigilance system in Nigeria
- Identify existing gaps in the current policy and proffer pragmatic methodologies in closing these gaps
- Integrate recent developments and advances in pharmacovigilance into the revised document in line with global best practices particularly e-reporting and repository advancements for pharmacovigilance information, archival and storage.
- Engage identified government officials, development partners, academia, public and private sector health care professionals, healthcare professional bodies, patients and consumer affiliates in reviewing and updating the current policy.
- Expand implementation framework for pharmacovigilance in Nigeria
- Prepare a policy brief for submission to the Honourable Minister of Health (HMH)
- Prepare and submit a bound copy of the reviewed policy to the Director-General (NAFDAC)
Policy brief for the HMH:
- Final Draft of the “Nigerian National Pharmacovigilance Policy and Implementation 2019” for the signature of the HMH
Qualifications and Experience
- A minimum of PhD in Medicine, Pharmacy, Pharmacology, Medical Sciences, Public health or any other related discipline is required. Qualifications and/or professional certifications in Pharmacovigilance will be an added advantage.
Prior Work Experience:
- A minimum of twenty (20) years cognate experience in public and private sector health organizations is highly desirable.
- A minimum of five years of progressively responsible professional level experience in medicine regulation, pharmacovigilance, policy formulation and development is required. Evidence of policy formulation, development and review in the last ten (10) years
- A level 4 proficiency in English for speaking, reading and writing is required.
- Expert knowledge of the major issues affecting pharmacovigilance in the Nigerian health system and a sound understanding of modern issues in pharmacovigilance systems along with demonstrated knowledge of existing public health programs in Nigeria is required.
- Familiarity with public and private sector engagements in the practice of pharmacovigilance is required.
- Expert knowledge of global best practices for pharmacovigilance and methodologies for policy formulation, development and implementation is highly desirable.
- Knowledge of pharmacovigilance structure and functions, roles and responsibilities of other stakeholders is highly desirable.
Skills and Abilities:
- Strong interpersonal skills, including ability to work effectively in a team and with senior level public and private sector officials, academia, development partners and other stakeholders in pharmacovigilance are required.
- Applicants must demonstrate that they are able to develop effective project manager relationships with stakeholders in the review and update of the pharmacovigilance policy.
- Excellent organizational skills and the ability to multi-task and stay organized in a complex, frequently changing environment is a requirement.
- Applicants must demonstrate advanced analytical skills and problem solving, as well as the ability to effectively manage stress and conflict.
- Experience in managing and supervising professional project management staff within a culturally diverse international setting is desirable.
- An applicant is expected to have the following minimum computer skills: fully functional in Windows, MS Excel, word processing and PowerPoint; and fully functional in using the internet to solve problems and research information, such as regulatory guidance.
Evaluation and Selection
After the closing date for receipt of applications, all applications will initially be screened for conformity with minimum qualifications expressed in Section 6. Those applications that meet the required minimum qualifications will be assessed based on the following selection/evaluation criteria:
- Education (10 points)
- Prior Work Experience (20 points)
- Language Proficiency (10 points)
- Job Knowledge (30 points)
- Skills and abilities (30 points)