Drug Safety Associate I

Role overview

Corbus Pharmaceuticals is creating its first internal pharmacovigilance function to support an expanding late-stage pipeline. In this position, you will be the main case processor for individual case safety reports (ICSRs), handling intake and data entry from start to finish in Veeva Vault Safety. You will also help make sure expedited regulatory submissions are completed within ICH E2B and FDA/EMA deadlines. This is a practical, operations-focused opportunity for someone early in their scientific career who wants to grow strong PV expertise in a fast-moving biotech environment.

Key responsibilities

• Review, route, and process all incoming ICSRs, including spontaneous reports, clinical trial cases, and literature cases, in Veeva Vault Safety.
• Code adverse events, indications, and suspect/concomitant medicines using MedDRA and WHODrug.
• Evaluate seriousness, expectedness based on the current Investigator’s Brochure or SmPC, and causality using source records.
• Draft or prepare initial case narratives in line with ICH E2B(R3) and internal SOPs.
• File 7-day and 15-day expedited ICSRs with FDA, EMA, and other relevant authorities within required timelines.
• Keep case files accurate and complete in Veeva Vault Safety and complete quality checks before case lock.
• Send follow-up requests to clinical sites, reporters, and CROs when case details are missing or incomplete.
• Support transfer of legacy CSPC safety data, around 260 cases from 4 studies, into Vault Safety.
• Reconcile case information with Veeva EDC and partner safety systems as needed.
• Help prepare line listings and case data extracts for DSURs and PBRERs.
• Assist with writing and maintaining SOPs as in-house PV processes are established.
• Take part in audit and inspection-preparedness work and retrieve case documentation when requested.
• Support periodic reconciliation activities with CROs and clinical partners.

Qualifications

The role calls for a bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field, plus 3–4 years of experience in drug safety, pharmacovigilance, clinical research, or another regulated life-sciences role. You should understand ICH E2B, ICH E2A, FDA 21 CFR 312.32, and EMA GVP Module VI requirements, and have working knowledge of MedDRA terminology. Strong attention to detail, the ability to handle regulatory deadlines, and excellent written English for narrative writing are important.

Preferred background

Hands-on experience with Veeva Vault Safety, Oracle Argus, or ARISg is preferred, as is exposure to a clinical trial setting from the CRO, site, or sponsor side. Internship or co-op experience in a pharmaceutical or biotech pharmacovigilance role is also valued, along with familiarity with safety-EDC reconciliation workflows.

Technical skills

You should be comfortable using Veeva Vault Safety or a similar system for case processing, working with a MedDRA browser and WHODrug Global for coding, and using Microsoft Office tools such as Excel and Word. Experience with E2B(R3) electronic reporting through a gateway is helpful, though training can be provided if needed.

Why this role stands out

This is a foundational hire for Corbus’s first in-house PV team. The role offers direct exposure to regulatory strategy, aggregate reporting, and signal management—experience that often takes years to gain in larger organizations. The company also highlights competitive compensation, a collaborative science-led culture, and a development path toward a Senior or Specialist position.

Company culture

Corbus describes itself as a tight-knit global team of high-performing, creative, innovative, and passionate employees. The organization values personality as well as technical skill, and emphasizes a family-like environment where every contribution matters. Employees are encouraged to think creatively, act proactively, and work in a setting with little politics or bureaucracy.

About Corbus Pharmaceuticals

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments in oncology and obesity. Its mission is to help people overcome serious illness by advancing differentiated scientific approaches aimed at well-understood biological pathways with significant unmet medical need. The lead oncology program, CRB-701, is a next-generation antibody-drug conjugate targeting Nectin-4-expressing tumors and is being developed across multiple solid tumor indications. The obesity program, CRB-913, is a highly peripherally restricted CB1 receptor inverse agonist intended to support meaningful weight loss while limiting central nervous system side effects. The company is headquartered in Norwood, Massachusetts, operates in a collaborative entrepreneurial environment, and is an equal opportunity employer.

Additional information

This opening is based in the United States and is a full-time, onsite role. No salary, stipend, application deadline, or vacancy count was provided in the source information.