Responsibilities

As a Senior Safety Specialist, the individual will perform and 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 reviewing cases for quality and accuracy, providing assistance in developing program and departmental procedural documents, preparing for and attending audits, mentoring less experienced staff, reviewing regulatory/pharmacovigilance publications, maintaining medical understanding of therapeutic areas, and participating in routine project implementation and coordination, including presentations and review of metrics and budget considerations. They may also provide 24-hour coverage for case intake from investigative sites.