Senior Pharmacovigilance Manager

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds 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 1300 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 mindsregardless of backgroundto 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.

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:
Bachelors 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-bachelors progressive related work experience.
Must have seven (7) years of experience with/in:
ï Designing and implementing donor-funded projects within the pharmaceutical sector;
ï Engaging with global pharmaceutical stakeholders and contributing to international regulatory systems agendas and programs;
ï Pharmacovigilance systems including risk management signal detection and adverse event reporting;
ï Regulatory system strengthening activities including market authorization governance and policy market surveillance with an emphasis on pharmacovigilance;
ï International regulatory standards and guidelines including ICH WHO and GxP; and
ï Pharmacovigilance.
Telecommuting permitted on a hybrid schedule as determined by the employer.
Up to 25% domestic or international travel required

To apply please email resume to Sundar Nagarajan at and reference (MD0031)

Supervisory Responsibilities

None this is an individual contributor role.

40 hrs/week Mon-Fri 8:30 a.m.- 5:30 p.m. Salary: $183414/yr. Standard company benefits

Required Experience:

Manager