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 assesses adverse event reports from clinical trials and post-marketing sources
• Enters and maintains safety data in the global safety database and prepares safety reports for regulatory authorities
• Collaborates with cross-functional teams to ensure accurate reporting of adverse events and assists in developing safety procedures

Required Qualifications

• Degree in Pharmacy, Nursing, Life Science, or equivalent experience
• 2+ years of recent case processing experience, including post-marketing cases
• Experience with MedDRA and WHODrug coding
• Familiarity with pharmacovigilance regulations and safety database management
• Experience with RxLogix's Pharmacovigilance Case Management system is a plus