Job Description

Position Overview

Performs day-to-day pharmacovigilance (PV) activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

Responsibilities

• 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.

Requirements

• 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).

Work Schedule and Environment

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Location Type: [Not Specified]
• Salary: [Not Specified]
• Environmental Conditions: Office
• 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.

Application Instructions

[Not Specified]

Company Information

[Not Specified]