Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Works independently to perform 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. 
 Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. 
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. 
 Reviews cases entered for quality, consistency and accuracy, including review of peer reports. 
 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 5+ 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