**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
- 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