Pharmacovigilance Specialist

Pharmacovigilance Specialist Overview

• The Pharmacovigilance Specialist will oversee vendor and case processing deliverables, ensuring compliance with regulations and agreements.
• This role involves evaluating adverse event reports for accuracy and regulatory reporting criteria.
• Collaborates with regulatory personnel to ensure timely submission of adverse event reports.
• Supports the development and maintenance of SOPs, working practices, and training materials.
• Interacts with collaborators and functional peer groups to support vendor management and deliverables.
• Analyzes safety data for escalation and ensures effective communication of safety issues.
• Identifies process improvement areas and implements corrective and preventive actions as needed.
• This is a remote opportunity with flexible working hours, ideal for experienced professionals.

Pharmacovigilance Specialist Key Responsibilities & Duties

• Manage vendor and case processing deliverables in compliance with regulations and agreements.
• Regularly interact with case processing vendors to ensure timely adverse event report processing.
• Evaluate adverse event reports for accuracy and regulatory compliance.
• Monitor vendor performance metrics to ensure quality and compliance.
• Collaborate with regulatory teams for the submission of adverse event reports.
• Analyze safety data and facilitate the communication of safety issues effectively.
• Support DSMB data collation and reporting processes.
• Identify and address deviations from processes, implementing CAPA measures when required.

Pharmacovigilance Specialist Job Requirements

• Bachelor's degree in a relevant field, with a BSN highly preferred.
• Minimum of 5 years of experience in drug safety or pharmacovigilance.
• Proficiency with Argus Safety Database and familiarity with FDA, EU, and ICH guidelines.
• Strong critical thinking and problem-solving skills for managing case processing deliverables.
• Experience in developing and maintaining SOPs, working practices, and training materials.
• Ability to manage vendor relationships and ensure compliance with quality standards.
• Excellent communication skills for effective collaboration with internal and external stakeholders.