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Drug Safety Associate I
Corbus PharmaceuticalsDrug Safety Associate I at Corbus Pharmaceuticals processing ICSRs and managing regulatory submissions. Building in-house pharmacovigilance expertise in a high-growth biotech environment.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in ICSR case processing, including MedDRA and WHODrug coding, regulatory submissions, and maintaining compliance with ICH E2B(R3) standards. Proficient in using Veeva Vault Safety for data management and reconciliation in pharmacovigilance.
Highest-signal resume keywords
ICSR Case ProcessingMedDRA CodingVeeva Vault SafetyRegulatory SubmissionsPharmacovigilance Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
MedDRA TerminologyWHODrug CodingData EntryCase Narrative AuthoringRegulatory ComplianceSafety Data ReconciliationQuality ChecksCase Record MaintenanceClinical ResearchPharmacovigilance
Soft Skills
Attention to DetailTime ManagementWritten Communication
Tools & Technologies
Veeva Vault SafetyOracle ArgusARISg
Industry Keywords
ICH E2BFDA 21 CFR 312.32EMA GVP Module VIClinical TrialsCRO
Tech Stack
Tools & technologiesOracleVault
About the role
Key responsibilities & impact- Serve as the primary ICSR case processor, managing end-to-end intake and data entry in Veeva Vault Safety
- 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
Requirements
What you’ll need- 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
Comp & perks- Competitive compensation
- Collaborative science-driven culture
- Clear development pathway toward a Senior or Specialist role