Brief Job Overview
Provide technical oversight and implementation on donor-funded projects related to Pharmacovigilance (PV) and adjacent Regulatory Services Strengthening (RSS) activities. Work with NRAs and regional regulatory agencies to strengthen the PV Legal Framework and Guidelines. Assess and identify gaps in PV legal frameworks of NRAs and Regional Ethics Committees (RECs). Develop and advocate for new laws, directives, regulations, policies, and guidelines consistent with international standards. Facilitate regional approaches to safety surveillance using mutually agreed and recognized guidelines. Support developing proposals involving PV and some related RSS activities. Support new business development opportunities that relate to RSS. Identify, review, develop, and continuously improve technical approaches to Global Health and Manufacturing Services (GHMS) core areas. Identify new and adjacent areas in PV and RSS for GHMS to contribute by identifying needs, developing plans. Support donor engagement/prime engagement. Support the onboarding of new staff who need technical orientation.
MINIMUM REQUIREMENTS:
Bachelor's degree or foreign equivalent degree in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Public Health, Global Health, Medical Sciences, or a related field, and seven (7) years of post-bachelor's, progressive, related work experience.
Must have seven (7) years of experience with/in:
• Designing and implementing donor-funded projects within the pharmaceutical sector;
• Engaging with global pharmaceutical stakeholders and contributing to international regulatory systems agendas and programs;
• Pharmacovigilance systems, including risk management, signal detection, and adverse event reporting;
• Regulatory system strengthening activities including market authorization, governance and policy, market surveillance, with an emphasis on pharmacovigilance;
• International regulatory standards and guidelines, including ICH, WHO, and GxP; and
• Pharmacovigilance.
Telecommuting permitted on a hybrid schedule as determined by the employer.
Up to 25% domestic or international travel required
Supervisory Responsibilities
None, this is an individual contributor role.
40 hrs/week, Mon-Fri, 8:30 a.m.- 5:30 p.m. Salary: $183,414/yr. Standard company benefits
