The Senior Technical Advisor – PV/PVMIS provides technical assistance to the relevant entities under Ministries of Health in MTaPS supported countries to build capacity and strengthen the pharmacovigilance system including use of existing Pharmacovigilance management information systems such as PViMS and VigiFlow.
Technical Support (50%)
- Support Medicines, Technologies and Pharmaceutical Services (MTaPS) and the MOH in assessing the PV capacity of supported countries, identifying priority gaps and determining most feasible options to address these gaps.
- Support MTaPS to select and adopt technical strategies and frameworks for designing, planning, and implementing strategies and interventions necessary for strengthening pharmacovigilance and pharmacovigilance management information systems in supported countries
- Oversee the implementation of technical assistance activities for PV & pharmacovigilance management information systems in supported countries ensuring that products and deliverables meet quality standards and clearly contribute to the overall MTaPS goals.
- With support from Head Office based and regional based technical teams, work with the MOH and national medicines regulators in supported countries to strengthen their pharmacovigilance functions including reviewing institutional development plans (IDPs) to identify critical areas of support, the establishment of active surveillance for newly introduced medicines and vaccines
- Support countries to promote reporting and analysis of adverse events, from the use of medicines and related health products, including COVID-19 products
- Support MOH and NMRAs to review and strengthen pharmacovigilance management information system, its processes and tools, including PViMS, VigiFlow, VigiBase, and other relevant tools
- Provide technical support for the development and implementation of appropriate strategies and guidelines for the strengthening of pharmacovigilance management information systems at national, regional and health facility levels
- Work with HO technical team and other MTaPS technical teams in the country to maintain the functioning of and facilitate the upgrading/updating of MTaPS-supported tools and systems including integration and interoperability with the existing national systems
- Prepare and give technical presentations on key project activities and achievements as needed.
- Work closely with the MTaPS technical Team, subject matter experts, and the Senior Manager(s) to develop and monitor appropriate/adequate budgets to support relevant technical activities.
- Work closely with other MTaPS country team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
- Monitor and report regularly to the Principal Technical Advisor PV/RSS on progress/results achieved in technical work plans and barriers encountered, and resolve any challenges faced.
- Represent the program at various technical meetings with other cooperating agencies and participate in various working groups as required, including making technical presentations on key activities and achievements of assigned areas as needed.
Capacity Building (20%)
- Contribute to the design, implementation and monitoring of capacity building activities related to PV and pharmacovigilance management information system that would benefit all countries .
- As required, participate in the planning and delivery of broader capacity building programs aimed at national regulatory system strengthening.
- Carry out additional responsibilities as may be assigned from time to time.
Monitoring and Evaluation (10%)
- In coordination with other team members in the country and head office, contribute to the development of country project M&E plan, and support the collection and validation of relevant data to report on project indicators.
- Contribute to the adequate documentation and dissemination of program results and lessons learned, including the development and submission of abstracts and articles to scientific journals and conferences.
Advanced Degree in pharmacy, medicine, pharmacology, health management, or public health with other relevant disciplines and hands on experience in public health programs especially related to health, medicines regulation and patient safety and/or pharmaceutical/pharmacovigilance management information system.
Preferred: Master’s Degree in a public health, or health related field.
Required: At least 7 years of relevant experience in the areas of pharmaceuticals management, pharmacovigilance, patient safety, regulatory system strengthening or health technologies management, preferably with international donors and organizations such as USAID, Global Fund, UN agencies-WHO, UNICEF and World Bank. Fluency in written and spoken French and English language.
- Demonstrated experience in developing and implementing regulatory and/or pharmacovigilance systems strengthening interventions obtained from working with a national regulatory authority, a pharmacovigilance center, or from the pharmaceutical industry in a French speaking country.
- Demonstrated experience in implementing or supporting regulatory information system or health information system and coordination in low- and middle-income countries desired.
- Knowledge of international regulatory and pharmacovigilance guidelines (e.g., WHO, ICH, etc.)
Knowledge & Skills
- Strong knowledge and understanding of regulatory systems including health systems of low and middle-income countries preferably in Africa
- Advanced knowledge and understanding of pharmacovigilance concept, principles and strategies including managing adverse reactions data
- In-depth understanding and experience with using pharmacovigilance management information system tools such as PViMS and VigiFlow.
- Experience in providing technical assistance on management information systems and implementing paper and electronic based information tools to strengthen health/pharmacovigilance systems desired.
- Strong organizational skills and ability to work in a team-oriented, culturally diverse environment.
- Excellent interpersonal skills, sound judgment, communication skills, training experience, ability to identify and resolve policy and operational constraints.
- Experience and ability working with senior government officials.
- Experience with USAID and other donor agencies desirable.
- Excellent reading, written and verbal communication and presentation skills in English and French
- Demonstrated skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint. Familiarity with Microsoft Project a plus.
- Fluency in French required including speaking, writing, and reading.
- Functional competencies: Highly motivated, resourceful, results driven and persistent. Ability to think strategically, gather and analyze information in order to make appropriate decisions. Strong interpersonal and communication skills.
- Core MSH competencies: adaptability, communication, problem solving, creativity and innovation, timeliness of work, quality of work and team relationships, resource utilization.
- Sound judgment, self-motivated, strong initiative.
Travel may be required