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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Veeva Vault Safety (or equivalent) — data entry and case processing.
• E2B(R3) electronic reporting via gateway (training provided if needed).

• Competitive compensation.
• Collaborative science‑driven culture.
• Clear development pathway toward a Senior or Specialist role.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.