Drug Safety Associate I – Contractor

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

📋 Description

• Assist the ICSR case processor by overseeing the complete intake and data entry process within Veeva Vault Safety.

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

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

• Write or draft initial case narratives in compliance with ICH E2B(R3) and company SOPs.

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

• Ensure accurate and thorough case records are maintained in Veeva Vault Safety; perform quality checks prior to finalization.

• Carry out follow-up requests with clinical sites, reporters, and CROs to obtain missing or incomplete case details.

• Aid in the transfer of legacy CSPC safety data (approximately 260 cases from 4 studies) into Vault Safety.

• Assist in the creation of line listings and case data extracts for DSURs and PBRERs.

• Contribute to the authoring and maintenance of SOPs as pharmacovigilance processes are developed internally.

• Engage in audit and inspection preparedness activities; provide case documentation as needed.

• Assist with periodic reconciliation tasks involving CROs and clinical partners.

⛳️ Requirements

• A 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 comparable regulated life-sciences position.

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

• Proficient understanding of MedDRA terminology.

• Strong attention to detail with the capability to meet regulatory deadlines.

• Excellent written English skills for narrative writing.

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

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

• Internship or co-op experience in a pharmaceutical or biotech pharmacovigilance environment is preferred.

• Understanding of safety-EDC reconciliation workflows is preferred.

🏝️ Benefits

• Competitive compensation

• Collaborative science-driven culture

• Clear development pathway toward a Senior or Specialist role