Principal Safety Specialist

Job Description

Responsible for the overall planning, co-ordination and delivery of pharmacovigilance services for large, complex projects. Oversee and may perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May directly oversee staff and provide input on individual performance.

A day in the Life:
* Works independently to oversee day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites .
* Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
* Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
* Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
* Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.