Drug Safety Specialist

Job Summary

A company is looking for a Drug Safety Specialist responsible for case processing of adverse events and related project information.

Key Responsibilities

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

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
• Familiarity with pharmacovigilance regulations and procedures
• Experience with RxLogix's Pharmacovigilance Case Management system is a plus