Drug Safety Specialist

Job Summary

A company is looking for a Drug Safety Specialist.

Key Responsibilities

• Reviews, processes, and assesses adverse event reports from clinical trials and post-marketing sources
• Prepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirements
• Collaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies

Required Qualifications

• Degree in Pharmacy, Nursing, Life Science, or equivalent qualification/work experience
• 2+ years of recent case processing experience, including post-marketing cases
• Experience with MedDRA and WHODrug coding
• Fluency in English
• Experience with RxLogix's Pharmacovigilance Case Management system is a plus