Remote, Mexico
2 days ago
Principal Safety Spec

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions and Other Job Information

Works independently to oversee day-to-day PV activities. May participate in oncall 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.

Qualifications: 
Education and Experience: 
Bachelor's degree or equivalent and relevant formal academic / vocational qualification 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). 

Working Conditions and Environment: 
 Work is performed in an office environment with exposure to electrical office equipment 
 Daily exposure to high pressure and intense concentration 
 Daily interactions with clients/associates 
 Long, varied hours on occasion 
 Travel required on occasion domestic and/or internationa

Confirmar seu email: Enviar Email