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, is providing 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, good pharmacy practices, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.
The MTaPS program is looking for specialists to provide technical assistance to DDA, MoHP, Department of Health Services (DoHS) and health facility level to build capacity and strengthen pharmacovigilance area as part of the broader regulatory systems strengthening work of USAID MTaPS.
Technical Support (60%)
- Assist in the development and implementation of the strategic plans and guidelines on pharmacovigilance
- Review the current laws and regulations for the establishment of a drug safety advisory committee in Nepal
- Draft/Develop Terms of reference for the establishment of the drug safety advisory committee
- Assist in drafting relevant pharmacovigilance regulations, guidelines and SOPs
- Participate in conducting pharmacovigilance systems assessments working with stakeholders to identify priorities and strategies for improvement, as needed
- Assist in the development of a detailed implementation plan in line with recommendations after Global Benchmarking Tool (GBT) maturity level assessment on PV
- Assist in the development of system requirement specifications for PV management information systems
- Assist in the implementation and training on the PV module (PViMS) and/or Vigiflow and PV strengthening training at central, provincial DDA offices and regional PV centers.
- Assist in the digitization of drug information, PV related activities at DDA/MoHP.
- Support DDA to specify requirements to pharmacovigilance management information systems, manage development and implementation of the Pharmadex pharmacovigilance module in close collaboration with DDA and Management Sciences for Health home office Pharmadex experts and programmers.
- Perform other tasks related to drug information and PV assigned by DDA and MTaPS
Capacity Building (20%)
- Develop capacity building strategies and plans needed to streamline AE reporting implement the Pharmadex and improve data analysis and use.
- Provide technical support in capacity building of DDA, regional PV centers and health facilities including timely implementation of work plan capacity building strategies and plans such as those for PViMS and/or Vigiflow users at regional PV centers, principles of pharmacovigilance, pharmacovigilance data analysis and interpretation, use of data for decision making
- Develop regulations, guidelines and manuals/SOPs for AE reporting by regional PV centers, public health programs, health care providers
- Work with relevant partners to build sustainable capacity of DDA and regional/provincial offices for effective PV implementation.
- Develop and present detailed implementation and work plans, track progress and manage the implementation of planned activities to meet set targets timely and satisfactorily
- Work closely with the DDA management team to develop realistic implementation plans, coordinate and manage implementation and report regularly on progress
- 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 agreed by the DDA management.
- Report regularly to the MTaPS 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 program reporting
- Represent the MTaPS 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, regional/provincial DDA offices, MOHP and other key stakeholders to ensure smooth PV work planning and implementation.
- Work closely with other MTaPS team members to ensure technical work plans are being implemented in a timely and sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
- Support DDA and MOHP to engaging stakeholders to implement relevant strategies to strengthen pharmacovigilance such as through stakeholder consultations, facilitation of multistakeholder workshops.
Required Qualification & Experience
Bachelor’s degree in pharmacy specialized training relating to pharmacovigilance preferred.
REQUIRED MINIMUM EXPEREINCE
- At least 4 years of relevant experience in areas of pharmacovigilance, medicines regulations, in LMICs, preferably in Nepal
- Experience in establishing and/or strengthening regulatory systems with particular focus on pharmacovigilance
- Experience in supporting pharmacovigilance policy, regulations, guidelines, standard operating procedures (SOPs) and terms of references (TORs) development including facilitation of stakeholder engagement and consultative workshops
- Documented expertise in Hospital Therapeutic Committee/Drug and Therapeutics Committee
- Strong program management and planning experience, with good analytical and reporting skills and an excellent communicator.
- Demonstrated experience with pharmacovigilance data collection, analysis, interpretation and use for decision making including experience with information systems such as Vigiflow and PViMS
- Good understanding of guidelines and WHO best practices for pharmacovigilance
- Demonstrated experience in developing and implementing capacity building strategies for pharmacovigilance including development and implementation of e-learning courses, training workshops, supportive supervisors, on the job trainings etc.
- Experience in writing/developing reports, training materials, and presentations
- Experience in pharmacovigilance data collection, cleaning, analysis, data entry into relevant tools such as Vigiflow and/or PViMS
- Familiarity with the WHO GBT to assess regulatory systems, especially on the vigilance function.
- Previous experience in working with national drug regulatory authority is preferred
KNOWLEDGE AND SKILLS
- Strong knowledge and understanding of regulatory systems and the functions of national regulatory authorities including pharmacovigilance.
- Knowledge and experience with pharmacovigilance concepts
- Strong skills and experience in drug safety and related pharmaceutical management Information System
- 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 adverse event (AE) reporting and analysis platforms.
- Experience in conducting pharmacovigilance systems assessments in LMICs, preferably Nepal, and working with stakeholders to identify priorities and strategies for improvement.
- Demonstrated experience in engaging stakeholders to implement relevant PV strategies such as through stakeholder consultations, facilitation of multistakeholder workshops.
- Demonstrated skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint.
- Familiarity with Vigiflow and/or PViMS.
- 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, communicating and engaging with senior government officials.
- Experience working with USAID and other donor agencies desirable.
- Excellent written and verbal communication and presentation skills in English and Nepali are essential.
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. Willing to take responsibility for defined and agreed tasks and ensure compliance with agreed timelines and deliverables. Strong interpersonal and communication skills.
Core MSH competencies: adaptability, communication, problem solving, creativity and innovation, timeliness of work, quality of work and team relationships, sound resource utilization.
Core Personal Competencies: Ethics and Values, Integrity and Trust, Listening, Written Communication
- Ability to work independently and effectively in a team.
- Good judgment for decision making.
- Strong interpersonal and communication skills.
- Ability in consensus building and constructively leading a team.
- Travel requirements to the regional PV centers and health facilities
- Keyboard use, pulling drawers, lifting papers <10 lbs., etc.
How to Apply
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.
EEO is the Law – English
EEO is the Law – Spanish
EEO is the Law Supplement
Pay Transparency Nondiscrimination Poster (url: https://www.msh.org/sites/msh.org/files/ofccp_paytransparencynotice_formatted_poster_1.pdf)
MSH EEO-AA Policy (url: https://www.msh.org/sites/msh.org/files/eeo-aa_policy_statement_msh_final_9.17.15.pdf)