Drug Safety Associate

Job Summary

To support a growing late-stage portfolio, the full-time Drug Safety Associate I will manage end-to-end intake and data entry in Veeva Vault Safety, ensuring compliance with regulatory submissions while working remotely.

Key Responsibilities

• Process incoming ICSRs and perform MedDRA and WHODrug coding for adverse events
• Maintain accurate case records and execute follow-up requests for missing information
• Assist in regulatory compliance activities, including preparation of case data extracts and SOP maintenance

Required Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare discipline
• 3-4 years of experience in drug safety/pharmacovigilance or clinical research
• Familiarity with ICH E2B, FDA 21 CFR 312.32, and EMA GVP Module VI reporting requirements
• Working knowledge of MedDRA terminology
• Excellent written English for narrative authoring