Drug Safety Associate I

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the main processor for ICSR cases, overseeing the complete intake and data entry process in Veeva Vault Safety.

• Receive, triage, and manage all incoming ICSRs — including spontaneous reports, clinical trials, and literature — within Veeva Vault Safety.

• Conduct MedDRA and WHODrug coding for adverse events, indications, and suspect/concomitant medications.

• Evaluate case seriousness, expectedness (according to the current IB/SmPC), and causality based on source documents.

• Create or draft initial case narratives following ICH E2B(R3) guidelines and company SOPs.

• Submit expedited ICSRs (7-day and 15-day) to the FDA, EMA, and other relevant health authorities within regulatory timelines.

• Ensure accurate and complete case records are maintained in Veeva Vault Safety; perform quality checks before locking cases.

• Carry out follow-up requests to clinical sites, reporters, and CROs for any missing or incomplete case information.

• Assist in the migration of legacy CSPC safety data (~260 cases across 4 studies) into Vault Safety.

• Reconcile cases with Veeva EDC and partner safety databases as needed.

• Aid in the preparation of line listings and case data extracts for DSURs and PBRERs.

• Contribute to the creation and maintenance of SOPs as pharmacovigilance processes are developed in-house.

• Engage in audit and inspection readiness activities; retrieve case documentation upon request.

• Support regular reconciliation activities with CROs and clinical partners.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.

• 3-4 years of experience in drug safety/pharmacovigilance, clinical research, or a similar regulated life sciences position.

• Understanding of ICH E2B, ICH E2A, FDA 21 CFR 312.32, and EMA GVP Module VI reporting requirements.

• Proficient knowledge of MedDRA terminology.

• Strong attention to detail and capability to meet regulatory deadlines.

• Excellent written English skills for narrative composition.

• Prior hands-on experience with Veeva Vault Safety, Oracle Argus, or ARISg is preferred.

• Familiarity with clinical trial environments (CRO, site, or sponsor side) is preferred.

• Internship or co-op experience in a pharmaceutical or biotech PV setting is preferred.

• Knowledge of safety-EDC reconciliation workflows is preferred.

🏝️ Benefits

• Competitive compensation.

• Collaborative, science-driven culture.

• Clear development pathway toward a Senior or Specialist role.