Job Description

Corbus Pharmaceuticals is building its first in‑house pharmacovigilance team to support a growing late‑stage portfolio. The Drug Safety Associate I will serve as the primary ICSR case processor, 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 hands‑on operational role ideal for a new‑to‑industry scientist eager to build deep PV expertise in a high‑growth biotech setting. This is a hybrid role to Norwood, MA requiring 3 days on site and 2 days remote weekly. Key Responsibilities Case Processing & Data Entry Receive, triage, and process all incoming ICSR cases — 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 ICSR cases 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. Qualifications Required 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. Excellent written English for narrative authoring. Preferred 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. MedDRA browser / WHODrug Global (coding proficiency desired). Microsoft Office Suite (Excel for data review, Word for documentation). E2B(R3) electronic reporting via gateway (training provided if needed). Benefits & Career Growth This is a foundational hire in a first‑in‑kind in‑house PV team. The successful candidate will have direct visibility into regulatory strategy, aggregate reporting, and signal management — exposure that typically takes years to obtain at larger organisations. Competitive compensation, a collaborative science‑driven culture, and a clear development pathway toward a Senior or Specialist role. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer. #J-18808-Ljbffr

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