Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Essential Functions and Other Job InformationWorks 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