Job Description

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Position Overview

Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research, and tracking of safety information.

Responsibilities

• Coordinates and performs Pharmacovigilance activities such as:
  • Data entry
  • Coding and assessment of adverse events
  • Case review
  • Follow-up
  • Tracking of reports
  • Regulatory reporting activities
• Effectively collaborates with various parties, including:
  • Project team members
  • Client contacts
  • Investigators
  • Adverse event reporters
  • Third-party vendors
• May assist in the preparation of departmental and project-specific procedures and processes.
• May prepare for and attend audits, kick-off, and investigator meetings.

Requirements

• Experience performing Pharmacovigilance (PV) activities.
• Ability to work in a highly regulated environment with strict timelines.
• Familiarity with Good Manufacturing Practices (GMP) Safety Standards.

Application Instructions

Please refer to the original posting for application instructions.

Company Information

Please refer to the original posting for company information.