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Detailed Job Description / Requirements:
Senior Technical Advisor - Pharmaceutical Systems & MIS
The goal of the global five year USAID Medicines, Technologies and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) including other relevant implementing agencies to strengthen pharmaceutical systems including pharmaceutical sector governance, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.
The Senior Technical Advisor – Pharmaceutical Systems and MIS provides technical assistance to the MOHP, DDA and its regional/provincial offices including other relevant entities to build capacity and strengthen pharmaceutical regulatory information system, processes and management systems including monitoring and evaluation of the project implementation and effective coordination with relevant entities.
Technical Support (40%)
- Support DDA to review and strengthen pharmaceutical regulatory systems including registration processes, structure and tools, pharmaceutical regulatory information system, including through continuous quality improvement approaches.
- Provide technical leadership for the development and implementation of appropriate strategies for the strengthening of pharmaceutical regulatory information systems within DDA and also regional/provincial level
- In collaboration with other partners, support DDA to review its operational processes including regulatory aspects to improve licensing, inspection, pharmacovigilance, post-marketing surveillance, and enforcement systems and tools.
- 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
- Contribute to review and update and or develop relevant guidelines and SOPs related to regulatory system strengthening of DDA
- Prepare and give technical presentations on key project activities and achievements as needed.
- Work closely with the MTaPS Nepal Management Team and the Finance and Administration Manager to develop and monitor appropriate/adequate budgets to support relevant technical activities.
- Report regularly to the Country Program Director 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.
- Maintain close liaison and coordination with senior officials in the MOHP, DDA and regional/provincial offices and other key stakeholders e.g. WHO, USAID implementing partners, to ensure technical assistance activities are carried out with their active participation for building ownership.
- Work closely with other MTaPS 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.
Capacity Building (20%)
- Contribute to the design, implementation and monitoring of capacity building activities for DDA and MOHP to be included in the MTaPS Nepal workplan.
- Work with relevant partners to build sustainable capacity of DDA and regional/provincial offices for effective pharmaceutical regulatory information system
- Carry out additional responsibilities as may be assigned from time to time.
Monitoring and Evaluation (20%)
- Contribute to the development of MTaPS Nepal Performance Monitoring plan (PMP), and support the collection and validation of relevant data to report project indicators.
- Contribute to the adequate documentation and dissemination of program results and lessons learned, including the development and submission of project’s mandatory reports, technical documents and reports; and abstracts and articles for scientific journals and conferences.
Qualifications and Experience
- Advanced Degree in pharmacy, medicine, statistics, health management, business management or public health with other relevant discipline and hands on experience in public health programs especially related to medicine regulation.
- At least 7 years’ of relevant experience in areas of pharmaceuticals and or health technologies management, regulatory systems strengthening related projects, pharmacovigilance, preferably with international donors and organizations such as USAID, Global Fund, UN agencies-WHO and World Bank.
- Demonstrated experience in regulatory affairs specifically 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, PIC/S, EMA, FDA, GHTF, ISO, etc.)
- Demonstrated experience in developing and implementing regulatory and/or pharmacovigilance systems strengthening interventions obtained from working with national regulatory authority, national pharmacovigilance centers, or from the pharmaceutical industry preferred.
Knowledge and Skills:
- Strong knowledge and understanding of regulatory systems including health systems of low and middle-income countries preferably Nepal and other south Asian countries
- In-depth understanding of design, planning and functionalities of e-health related tools and also integration issues between tools desired.
- Significant experience in providing technical assistance on management information systems and implementing information manual and electronic tools to strengthen health/pharmaceutical 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 written and verbal communication and presentation skills in English.
- Demonstrated intermediate skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint. Familiarity with Microsoft Project a plus.
- English fluency required including speaking, writing, and reading; additional proficiency in Nepali or other Nepalese language a plus.
- 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.
- Ability to travel in-country to support technical activities.
- Willingness and ability to travel internationally, including to the US as needed
- Keyboard use, pulling drawers, lifting papers <10lbs.
Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in over 150 countries with policy makers, health professionals, and health care consumers to improve the quality, availability and affordability of health services. Working with governments, donors, non governmental organizations, the private sector, and health agencies, MSH responds to priority health problems such as HIV & AIDS; tuberculosis; malaria; maternal, newborn and child health; family planning and reproductive health; and chronic non-communicable diseases such as cancer, diabetes, and lung and heart disease. Through strengthening capacity, investing in health systems innovation, building the evidence base, and advocating for sound public health policy, MSH is committed to making a lasting difference in global health.
Management Sciences for Health is an equal opportunity employer offering employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, citizenship, physical or mental disability, or veteran status.
Reports To: Country Project Director
Please submit all CVs and application materials in English
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|Please check vacancy details|
|28 Jun, 19|
|27 Jul, 19|