Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.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.Reviews cases entered for quality, consistency and accuracy, including review of peer reports.Prepares and maintains regulatory safety reports.Assists with 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.Mentors less experienced staff.

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 2+ 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 international