Drug Safety Associate II

Job Summary

Managing complex pharmacovigilance tasks, the full-time remote Drug Safety Associate II will independently process and quality-review ICSRs and SUSARs, assist with aggregate report preparation, and mentor junior associates while leveraging expertise in Veeva Vault Safety and regulatory compliance.

Key Responsibilities

• Independently process and quality-review complex ICSRs, SUSARs, and cases of special interest
• Assist with aggregate report preparation and maintain safety documentation for signal detection
• Mentor junior associates and oversee case quality control while managing Veeva Vault Safety configurations

Required Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related discipline; Master's, PharmD, or RN preferred
• 5+ years of pharmacovigilance experience in the pharmaceutical, biotech, or CRO industry
• Proficiency in Veeva Vault Safety or Oracle Argus for case processing and reporting
• Experience authoring DSURs and/or PBRERs with strong technical writing skills
• Deep knowledge of relevant FDA and EMA regulations and expert-level MedDRA coding experience