Drug Safety Associate I

Corbus Pharmaceuticals Inc • Norwood, MA

7d • Hybrid

About The Position

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.

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.
• 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).

Nice To Haves

• 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.

Responsibilities

• Receive, triage, and process all incoming ICSRs — 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 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.
• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level