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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.
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
MedDRA TerminologyWHODrug CodingData EntryCase Narrative AuthoringRegulatory ComplianceSafety Data ReconciliationQuality ChecksCase Record MaintenanceClinical ResearchPharmacovigilance
Soft Skills
Attention to DetailTime ManagementWritten Communication