Drug Safety Associate

Role: Drug Safety Associate I supporting in-house pharmacovigilance for a late-stage biopharma portfolio, primarily managing ICSR case processing and data entry. Responsibilities: handle all incoming adverse event reports (spontaneous, clinical trial, literature), perform MedDRA/WHODrug coding, assess case seriousness, author narratives, and ensure timely regulatory submissions; maintain data integrity in Veeva Vault Safety, support data reconciliation and migration, assist in preparing safety reports (DSURs, PBRERs), and contribute to SOPs and audit activities. Requirements: Bachelor's in Pharmacy, Nursing, or Life Sciences; 3-4 years in drug safety, familiarity with ICH E2B, FDA/EMA regulations, MedDRA; strong attention to detail and communication skills. Preferred: experience with Veeva Vault Safety, clinical trial environment exposure, safety reconciliation workflows. HighValue: pharmacovigilance, regulated life sciences, GxP compliance, Veeva Vault Safety, adverse event management, regulatory reporting. WorkSetup: hybrid (3 days onsite, 2 remote) in Norwood, MA.