PQM+ is currently recruiting a Nairobi, Kenya-based consultant to support its work in Eastern African countries. The support will include technical oversight and coordination of Risk Based-Post Market Surveillance and other regulatory system strengthening activities in line with PQM+ program objectives.
This is a temporary consultant position and support for this role by USAID/PQM+ will end by October 31, 2023.
Key Responsibilities
1. Provide technical support on Risk Based-Post Market Surveillance (RB-PMS) activities (IGAD and EAC regional PMS reports).
2. Provide technical support for Laboratory capacity assessment (IGAD member states).
3. Provide technical support on any assigned activities.
4. Monitor and report on the implementation of PQM+-supported activities including progress and challenges encountered.
5. Coordinate with REC (IGAD and EAC) secretariat and its member state National Medical Regulatory Authorities (NMRAs) or National Quality Control Laboratories (NQCL) towards achieving assigned PQM+ objectives.
Deliverables
1. Report of the findings from prior PMS conducted by the identified RECs with applicable administrative and/or regulatory enforcement decisions or actions taken. This may include regulatory interventions (warning notice, recall, confiscation, fine, penal sanction, awareness raising, etc.) as reported by each of the NMRAs against substandard and falsified medicines confirmed cases.
2. Report on PMS results dissemination workshops by selected REC.
3. Report on the development and adoption of harmonized guidelines on RB-PMS by REC and member countries (Workshop reports).
4. Report on the assessment of the National Quality Control Laboratories and their ISO 17025 status or preparedness.
5. Summary consultancy report.
Qualifications and Experience
· Degree in pharmaceutical sciences, Biology, Chemistry or Pharmacy.
· Good project management skills.
· Ability to work in a team, and with a complex set of stakeholders.
· Self-motivated, and able to work with little or no supervision.
· Strong analytical, communication and report writing skills.
· Ability to build relationships and interact effectively with technical experts and donor agencies.
· Results driven with demonstrated successful outcomes.
· Ability to demonstrate the highest degree of ethics and integrity.
· Excellent interpersonal and organizational skills with strong attention to detail.
Preferred
· Experience working across Eastern African countries.
· Relevant postgraduate qualification.
· Experience with the PQM+ RB-PMS approach and report writing.
· USAID experience is strongly preferred.
Anticipated Period of Performance
June 19th, 2023 – October 31, 2023. Additional consultancy may be available depending on satisfactory work performance by the consultant.
This position is for Kenya based candidates only. No relocation assistance will be provided.
Minimal and regional travel may be required.
Please send CV, 3-References, and Hourly Rate to ATTN: Kifayatullah Danish; Senior Procurement Specialist, at GPH_Procurement@USP.org, cc Kifayatullah.Danish@USP.org by the closing date of June 9, 2023.
When submitting your application, write “Kenya Pharmaceutical Regulatory/QA System Strengthening Consultant” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. In 2019, USP was awarded the Promoting the Quality of Medicines Plus (PQM+) program, a 5-year USAID-funded global program designed to sustainably strengthen medical product quality assurance (QA) systems in low-and-middle income countries. The main objectives of PQM+ program include: to improve governance of medical product QA systems, improve country and regional regulatory QA systems, optimize, and increase financial resources for QA, increase supply (manufacture) of quality-assured essential medicines and advance global learning and operational agenda, for medical products quality assurance.
Since 2009, the African Union Development Agency (AUDA-NEPAD) has been collaborating with partners to implement the African Medicines Regulatory Harmonization Initiative (AMRH). The key goal of AMRH has been to develop a collaborative regional approach for medical product registration in Africa with a vision to gradually move from 55 countries acting independently to eight regional economic communities (RECs) supporting one African Medicines Agency (AMA). As part of an ongoing partner platform, PQM+ collaborates with AUDA-NEPAD to provide technical assistance to selected RECs to operationalize the newly formed AMA.
