**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
Essential Functions and Other Job Information:
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