Pharmacovigilance Specialist

Job Summary

To support global pharmacovigilance activities, the remote Pharmacovigilance Specialist will manage adverse event case reports, ensure compliance with regulatory timelines, and contribute to the quality of pharmacovigilance deliverables over a 12+ month contract period.

Key responsibilities

• Manage adverse event case reports, including processing and follow-up activities
• Draft and manage periodic safety update reports and signal detection reports
• Ensure compliance with pharmacovigilance activities through audits, inspections, and training documentation management

Required qualifications

• Experience in pharmacovigilance or drug safety
• Knowledge of global regulatory requirements related to pharmacovigilance
• Proficiency in data review, compilation, and analysis
• Ability to draft safety reports and respond to regulatory agency inquiries
• Experience with training and managing documentation related to pharmacovigilance procedures