Pharmacovigilance Lead

Position Overview

This role involves working independently to oversee the day-to-day pharmacovigilance (PV) activities. The position may include participation in on-call duties for specific projects to ensure 24-hour coverage for case intake from investigative sites.

Responsibilities

• Functions in a lead role, exercising independent judgment to troubleshoot and resolve project issues and identify areas for improvement.
• Serves as the primary point of contact in the absence of the manager.
• Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic areas and disease states.
• Participates in or leads departmental initiatives.
• Serves as a subject matter expert in a designated area.
• Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee).
• Includes presentations at client/investigator meetings.
• Includes review of metrics and budget considerations.

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 8+ years).

Work Schedule & Environment

• Employment Type: Full-time
• Work Schedule: Standard (Monday-Friday)
• Location Type: [Not Specified]
• Salary: [Not Specified]
• Environmental Conditions: Office
• Working Conditions:
  • 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]