Drug Safety Associate I (Contractor)

Drug Safety Associate I (Contractor) Corbus Pharmaceuticals is building its first in-house pharmacovigilance team to support a growing late-stage portfolio. The Drug Safety Associate I will support ICSR case processing, managing end-to-end intake and data entry in Veeva Vault Safety, and ensuring expedited regulatory submissions meet ICH E2B and FDA/EMA timelines. This is a temporary role part time for approximately 20 hours per week. Case Processing & Data Entry Receive, triage, and process all incoming ICDRs — spontaneous, clinical trial, and literature — in Veeva Vault Safety. Perform MedDRA and WHODrug coding for adverse events, indications, and suspect/concomitant medications. Assess case seriousness, expectedness (per current IB/SmPC), and causality against source documents. Author or draft initial case narratives in accordance with ICH E2B(R3) and company SOPs. Submit 7‑day and 15‑day expedited ICDRs to FDA, EMA, and other applicable health authorities within regulatory timelines. Database & Data Integrity Maintain accurate and complete case records in Veeva Vault Safety; apply quality checks before lock. Execute follow‑up requests to clinical sites, reporters, and CROs for missing or incomplete case information. Support migration of legacy CSPC safety data (~260 cases across 4 studies) into Vault Safety. Reconcile cases against Veeva EDC and partner safety databases as required. Regulatory & Compliance Support Assist in preparation of line listings and case data extracts for DSURs and PBRERs. Contribute to SOP authoring and maintenance as PV processes are established in-house. Participate in audit and inspection readiness activities; retrieve case documentation as requested. Support periodic reconciliation activities with CRO and clinical partners. Required Qualifications Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare discipline. 3-4 years of experience in drug safety/pharmacovigilance, clinical research, or a related regulated life‑sciences role. Familiarity with ICH E2B, ICH E2A, FDA 21 CFR 312.32, and EMA GVP Module VI reporting requirements. Working knowledge of MedDRA terminology. Strong attention to detail and ability to manage regulatory deadlines. Preferred Qualifications Prior hands‑on experience in Veeva Vault Safety, Oracle Argus, or ARISg. Exposure to clinical trial environments (CRO, site, or sponsor side). Internship or co‑op experience in a pharmaceutical or biotech PV setting. Familiarity with safety‑EDC reconciliation workflows. Technical Skills Veeva Vault Safety (or equivalent) — data entry and case processing. E2B(R3) electronic reporting via gateway (training provided if needed). Benefits Competitive compensation. Collaborative science‑driven culture. Clear development pathway toward a Senior or Specialist role. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer. #J-18808-Ljbffr Corbus Pharmaceuticals, Inc.