Responsibilities

The Sr Safety Specialist will perform and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, 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. Responsibilities include working independently on PV activities, participating in on-call duties, developing program and departmental procedural documents, preparing for and attending audits, mentoring less experienced staff, reviewing regulatory/pharmacovigilance publications, and maintaining medical understanding of therapeutic areas. The role also involves reviewing cases for quality and accuracy, participating in routine project implementation and coordination, preparing for and attending client/investigator meetings, and reviewing metrics and budget considerations.