Corbus Pharmaceuticals
51 - 200 employees
Founded 2016
🧬 Biotechnology
🔬 Science
đź’Š Pharmaceuticals
đź’° $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 II
🔥 0 minutes ago
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Corbus Pharmaceuticals
51 - 200 employees
Founded 2016
🧬 Biotechnology
🔬 Science
đź’Š Pharmaceuticals
đź’° $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.
đź“‹ Description
• Independently process and quality-review complex ICSRs, SUSARs, and cases of special interest across all Corbus programs. • Lead SUSAR causality assessment and blind review with the Medical Monitor; coordinate unblinding decisions per protocol. • Perform and document expectedness assessment against the Reference Safety Information (IB/SmPC); • Oversee 7- and 15-day expedited submission workflow; act as backup submitter and regulatory gateway owner. • QC case quality and narratives prepared by the junior associate; provide coaching and sign-off. • Maintain Safety meeting minutes, documentation for Signal detection and Safety trackers. • Generate ad hoc line listings and cumulative summaries for regulatory queries using Vault Safety analytics. • Regular Safety SOP review, assist in drafting and maintaining the Pharmacovigilance System Master File (PSMF) and procedural documents (SOPs, work instructions, templates) as needed. • Assist with PV audit and inspection preparation; respond to agency queries and manage post-inspection CAPAs. • Manage PV agreements (PVAs) with CRO and licensing partners; ensure compliance with contractual safety exchange timelines. • Represent PV on cross-functional teams (Clinical, Regulatory, Medical Affairs); provide safety input into protocol amendments and IBs. • Serve as functional administrator for Veeva Vault Safety: configure workflows, manage user access, and coordinate validation with IT. • Oversee Safety-EDC reconciliation between Vault Safety and Veeva EDC for ongoing trials. • Mentor and train the junior Drug Safety Associate; conduct case-level QC and provide structured development feedback.
🎯 Requirements
• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related discipline; Master's, PharmD, or RN strongly preferred. • 5+ years of progressive pharmacovigilance experience in the pharmaceutical, biotech, or CRO industry. • Demonstrated proficiency in Veeva Vault Safety or Oracle Argus for end-to-end case processing and reporting. • Hands-on experience authoring DSURs and/or PBRERs; strong technical writing skills. • Deep knowledge of ICH E2A, E2B(R3), E2C, E2D, E2E, FDA 21 CFR Part 312, and EMA GVP Modules I–IX. • Expert-level MedDRA coding; experience with signal detection methodologies. • Track record of direct regulatory interactions and safety committee participation. • Preferred: Experience in Oncology therapeutic area. • Prior sponsor-side experience at a small or mid-size biotech. • PSMF authoring and GVP Module VII experience. • E2B electronic gateway submissions (FDA ESG, ASK-EudraCT, VigiBase). • Veeva Vault Safety administrator or system validation experience.
🏖️ Benefits
• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events
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