Responsibilities

As a Senior Safety Specialist, the individual will perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, driven by strict timelines. This includes collection, monitoring, assessment, evaluation, research, and tracking of safety information, collaborating with project team members, client contacts, investigators, and third-party vendors. They will operate in a lead capacity, providing assistance in the development of program and departmental procedural documents, preparing for and attending audits, and mentoring less experienced staff. The role also involves reviewing regulatory/pharmacovigilance publications, maintaining medical understanding of applicable therapeutic areas, reviewing cases for quality and accuracy, and being responsible for routine project implementation and coordination, including presentations and metric review.