Corbus Pharmaceuticals
51 - 200 employees
Founded 2016
🧬 Biotechnology
🔬 Science
💊 Pharmaceuticals
💰 $46M Post-IPO Equity on 2020-02
Biotechnology • Science • Pharmaceuticals
Corbus Pharmaceuticals is a biotechnology company engaged in the research and development of novel therapeutics to address serious illnesses. Their current focus includes innovative studies in Nectin-4, Integrin Biology, and CB1R Inverse Agonist Biology. They are actively progressing in their clinical pipeline with treatments like CRB-601 for advanced solid tumors and CRB-701 for metastatic cervical cancer, which has received FDA Fast Track Designation. Corbus Pharmaceuticals aims to connect innovation with purpose, pushing the boundaries of medicinal research and offering new hope for challenging health conditions. The company is publicly traded on Nasdaq under the ticker CRBP.
Drug Safety Associate I – Contractor
🔥 0 minutes ago
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Corbus Pharmaceuticals
51 - 200 employees
Founded 2016
🧬 Biotechnology
🔬 Science
💊 Pharmaceuticals
💰 $46M Post-IPO Equity on 2020-02
Biotechnology • Science • Pharmaceuticals
Corbus Pharmaceuticals is a biotechnology company engaged in the research and development of novel therapeutics to address serious illnesses. Their current focus includes innovative studies in Nectin-4, Integrin Biology, and CB1R Inverse Agonist Biology. They are actively progressing in their clinical pipeline with treatments like CRB-601 for advanced solid tumors and CRB-701 for metastatic cervical cancer, which has received FDA Fast Track Designation. Corbus Pharmaceuticals aims to connect innovation with purpose, pushing the boundaries of medicinal research and offering new hope for challenging health conditions. The company is publicly traded on Nasdaq under the ticker CRBP.
📋 Description
• Support ICSR case processor, managing end-to-end intake and data entry 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 ICSRs to FDA, EMA, and other applicable health authorities within regulatory timelines. • 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. • 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.
🎯 Requirements
• 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. • Prior hands-on experience in Veeva Vault Safety, Oracle Argus, or ARISg (preferred). • Exposure to clinical trial environments (CRO, site, or sponsor side) (preferred). • Internship or co-op experience in a pharmaceutical or biotech PV setting (preferred). • Familiarity with safety-EDC reconciliation workflows (preferred).
🏖️ Benefits
• Competitive compensation • Collaborative science-driven culture • Clear development pathway toward a Senior or Specialist role
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