Technical Advisor – Management Information System Regulation

Website Management Sciences for Health

JOB OPPORTUNITY

Technical Advisor – Management Information System Regulation

Location: Nepal-Kathmandu

The Technical Advisor – Management information system regulation (TA-MISR) provides regulatory and MIS assistance to the Department of Drug Administration (DDA) and its provincial offices to build capacity and implement the pharmaceutical regulatory management information system (Pharmadex) at the DDA.

The Regulatory Advisor will support the regulation and implementation of Pharmadex, update systems and practices to align with World Health Organization (WHO) best practices linked to registration, inspection, pharmacovigilance, import and export and will develop and implement appropriate training strategies. The Regulatory Specialist will plan, manage, and report on the MTaPS implementation and effective coordination with DDA.

Specific Responsibilities:

Technical Support 40%

  • Support DDA to customize, test and implement Pharmadex for registration of pharmacies, wholesalers, importers, manufacturers, and products.
  • Support DDA to specify requirements to inspection management information systems. Manage development and implementation of the Pharmadex inspection module in close collaboration with DDA inspection Division and Management Sciences for Health (MSH) home office Pharmadex experts and MSH-programmers.
  • Support DDA to specify requirements to pharmacovigilance management information systems, manage development and implementation of the Pharmadex pharmacovigilance module in close collaboration with DDA Management, Planning and Coordination Division and Management Sciences for Health home office Pharmadex experts and programmers.
  • Support the development of electronic inspection tool and reporting/ integration into Pharmadex.
  • Support DDA to strengthen pharmaceutical regulatory systems including licensing, registration, pharmacovigilance and inspection processes, structure, and tools, Pharmaceutical Management Information System (PMIS), workflows and procedures through continuous quality improvement approaches and attainment of WHO best practices.
  • Provide technical support for implementation of Pharmadex within DDA central and provincial level
  • Support the DDA to strengthen their IT infrastructure, local area networking, IT solutions, information sharing and use.
  • Develop and implement capacity building strategies to build capacity in PMIS /Pharmadex use for DDA staff and other users including establishment of help desk and e-learning methods.
  • Ensure maintenance of templates and standard operating procedures.
  • In collaboration with the short-term technical adviser on data transfer and PMIS manage data transfer from DAMS to Pharmadex as needed.
  • Manage and record testing and reporting on issues and system revisions and ensure smooth coordination and communication with the MSH home office and programmers.
  • Ensuring handover of the system to DDA.

Coordination 20%

  • Develop and present detailed implementation and work plans, track progress and manage the implementation of planned activities to meet set targets timely and satisfactory
  • Work closely with the DDA management team to develop realistic implementation plans, coordinate and manage implementation and report regularly on progress and ensure expectation management
  • 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.
  • Take part in progress meetings with DDA, USAID and MTaPS team and contribute to all program reporting
  • 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 DDA and regional/provincial offices, MOHP and other key stakeholders to ensure smooth PMIS implementation and expectation clarification.
  • 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 40%

  • Develop capacity building strategies and methods needed to implement the Pharmadex and improve data use.
  • Implement training strategies for Pharmadex use by DDA staff and users of Pharmadex.
  • Develop guidelines and Manuals for use of PMIS and Pharmadex and reporting in Pharmadex.
  • Train DDA staffs in data use and report generation.
  • Train DDA inspectors in the use of the inspection modules.
  • Train DDA staff in data quality and assess data quality.
  • Work with relevant partners to build sustainable capacity of DDA and regional/provincial offices for effective pharmaceutical regulatory information system.
  • Write success stories and demonstrate Pharmadex.

QUALIFICATIONS
Education :

  • Required: Degree in pharmacy or public health with other relevant discipline and hands on experience in medicine regulation and management information systems.

Experience:

  • At least 3 years of relevant experience in areas of pharmaceuticals, medicines regulation, registration, and inspection.
  • Experience in health-related MIS like Pharmacy, Medicine etc.
  • Strong program management and planning experience, with good analytical and reporting skills and an excellent communicator.
  • Experience with government regulated medicine administration system like DAMS and Pharmadex.
  • Demonstrated experience in regulatory affairs and procedures specifically product registration and inspection gained from working with the DDA or pharmaceutical industry.
  • Good understanding of guidelines and WHO best practices for i.e. dossier review, Good Pharmacy Practices, Good Distribution Practices and Good Manufacturing Practices.
  • Demonstrated experience in developing and implementing capacity building strategies, e-learning courses, workshops etc. on Pharmaceutical related projects.
  • Experience in data quality assessment for health-related projects.

Skills, knowledge and competencies:

  • Strong knowledge and understanding of regulatory systems and the functions of national regulatory authorities.
  • Strong skills in IT and Management Information System (MIS).
  • Strong understanding of 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.
  • 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 issues and operational constraints.
  • Experience and ability working with senior government officials and communicate well.
  • 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, Redmine.
  • 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 to make appropriate decisions. Strong management and planning skills and good in following up and having the overview while also focusing on the details. Strong 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, and team player.

Travel requirements: Available to travel within the country
Keyboard use, Scanning, filing, pulling drawers,
Lifting papers <10lbs., ETC.

MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.

Website: https://msh.org/

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