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Senior Program Associate/Regulatory Affairs & Pharmacovigilance

OVERALL RESPONSIBILITIES

The Senior Program Associate (SPA) works closely with the Senior Technical Manager and the other CPM/SIAPS portfolio managers to support the implementation of CPM and SIAPS core, regional and country level activities in the areas of strengthening regulatory systems and pharmacovigilance in developing countries. The SPA provides support in the implementation of efficient regulatory systems including a comprehensive pharmacovigilance system that support access to and safe use of essential medicines. Successful candidate will work in close cooperation with national pharmacovigilance centers, medicines regulatory authorities, and ministry of health officials in developing countries. S/He assists in all planning, monitoring, documentation, and reporting activities relevant to designated program portfolios.

SPECIFIC RESPONSIBILITIES

  1. Provide technical support to country program managers for the development and/or review of work plans to ensure consistency with CPM approaches to pharmacovigilance and strengthening regulatory systems. Also provide direct technical input in the implementation of technical activities as required.

  2. Provide direct technical assistance to support the design and implementation of interventions in SIAPS countries for improving medicines regulation and pharmacovigilance systems.

  3. Provide training to staffs and in-country partners in international regulatory guidelines and how to adapt them to improve regulatory systems in developing countries

  4. Support the implementation of assessment and/or survey activities including the development of data collection and analysis tools; development of data collection guides; the development and implementation of data management plans for data processing and analysis; and the development of technical reports.

  5. Provide support for the development and review of protocols for operations research including active surveillance protocols for pharmacovigilance. Facilitate opportunities for multi-country studies on common themes and technical areas. Facilitate sharing technical approaches across several SIAPS countries and provide technical assistance in the implementation of operations research

  6. Support pharmaceutical management training activities including the development or adaptation of training materials and assist in the planning and delivery of CPM/SIAPS training programs.

  7. Assist CPM/SIAPS senior technical staff and consultants in the planning and implementation of field-based technical assistance activities. This includes coordinating with SIAPS field offices and with relevant partners whenever required.

  8. Collaborate with senior technical staff for the development and/or the review of technical reports.

  9. Assist designated senior technical staff in monitoring and reporting portfolio specific activities, deliverables and indicators.

  10. Participate in the development of communication materials, presentations, articles, abstracts and posters in the context of knowledge management and participate in the presentation of these products to various audiences and forums.

  11. Monitor budgets and sub-budgets, tracking accruals regularly using a computerized tracking system.

  12. Assist in developing MSH proposals and new technical assistance projects as needed.

  13. Perform other duties, as assigned.

QUALIFICATIONS

  1. Bachelor’s degree in biological, pharmaceutical, medical, or allied health sciences field

  2. Postgraduate degree in clinical pharmacology, pharmacovigilance, epidemiology, or regulatory affairs required;

  3. Demonstrated experience in regulatory affairs including registration, inspection, and post-marketing surveillance in low- and middle-income countries required;

  4. Minimum of 3 years experience in developing and implementing pharmacovigilance systems strengthening interventions obtained from working with national pharmacovigilance centers, national regulatory authority, or from the pharmaceutical industry;

  5. Knowledge of international regulatory and pharmacovigilance guidelines (e.g., WHO, ICH, PIC/S, EMA, FDA, GHTF), and African regional drug registration harmonization initiatives is desirable;

  6. Developing country experience or exposure to international development funding agency and/or technical support agencies will be a plus;

  7. Strong competencies in technical writing and good oral communication required with ability to develop technical briefs and conduct technical presentations;

  8. Demonstrated intermediate computer skills in Microsoft Office Suite applications, including Word, Excel, PowerPoint, Outlook and statistical software;

  9. Strong organizational skills with the ability to handle multiple tasks simultaneously, set priorities, and work independently;

  10. Excellent interpersonal skills and ability to work effectively in a team spirit, under pressure and a changing environment;

  11. Willingness and ability to travel internationally and domestically, as needed.

Note: There are no international relocation allowances available for this position.

Management Sciences for Health is an equal opportunity employer offering employment without regard to race, color, religion, sex, sexual orientation, age, national origin, citizenship, physical or mental handicap, or status as a disabled or Vietnam Era veteran of the U.S. Armed Forces.

To apply for this position, please visit the Employment Opportunities section of our website at https://jobs-msh.icims.com/jobs/4388/job. If you cannot apply online or have difficulty doing so, please email an explanation of your problem to iRecruiterproblem@msh.org.