Senior Pharmacovigilance Manager

USP•Rockville, MD

15h•Hybrid

About The Position

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. 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.

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.
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;
Pharmacovigilance.

Responsibilities

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.