Pharmacovigilance Specialist

Overview

• Provide expert pharmacovigilance support for vendor and case processing deliverables, ensuring compliance with global regulations and agreements.
• Collaborate remotely with cross-functional teams to manage adverse event reporting for investigational and marketed products.
• Evaluate adverse event reports for accuracy and regulatory compliance, exercising independent judgment in deliverables management.
• Perform vendor oversight activities, monitoring quality and compliance metrics for case processing.
• Support development and maintenance of SOPs, working practices, and training materials for pharmacovigilance operations.
• Analyze safety data for escalation and facilitate timely communication of safety issues.
• Engage with collaborators and management levels to ensure consistent and timely deliverables.
• Identify process improvement opportunities and perform root cause analysis for corrective actions.

Key Responsibilities & Duties

• Manage pharmacovigilance vendor deliverables, ensuring adherence to regulatory requirements and agreements.
• Interact with case processing vendors to ensure timely adverse event report processing.
• Evaluate adverse event reports for regulatory reporting criteria and accuracy.
• Collaborate with regulatory personnel for submissions of adverse event reports.
• Monitor vendor compliance metrics and oversee case processing quality.
• Develop and maintain SOPs, working practices, and training materials.
• Analyze safety data for escalation and communicate safety issues effectively.
• Perform root cause analysis and initiate corrective actions for process deviations.

Job Requirements

• Bachelor of Science in Nursing (BSN) or equivalent degree required.
• Minimum of 5 years’ experience in drug safety or pharmacovigilance; 7 years preferred.
• Proficiency in Argus Safety Database and familiarity with FDA, EU, and ICH guidelines.
• Strong critical thinking skills for managing timelines and escalating issues.
• Experience in vendor management and case processing oversight.
• Ability to analyze safety data and facilitate communication of safety concerns.
• Expertise in developing and maintaining SOPs and training materials.
• Knowledge of worldwide pharmacovigilance regulations and compliance requirements.