Responsibilities

As a Senior Safety Specialist, the individual will perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines, including collection, monitoring, assessment, evaluation, research, and tracking of safety information. They will collaborate with various parties such as project team members, client contacts, investigators, and adverse event/reporters, and third-party vendors. The role involves operating in a lead capacity, providing assistance in the development of program and departmental procedural documents, preparing for and attending audits, mentoring less experienced staff, reviewing regulatory/pharmacovigilance publications and information sources, reviewing cases for quality and accuracy, and being responsible for routine project implementation and coordination, including presentations at client/investigator meetings and review of metrics and budget considerations.