Drug Safety Associate III

Stamford, Connecticut

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Type: Contract

Experience: 0

Category: Scientific & Clinical

Contractor Work Model: Remote

Brand: Joulé

Job ID: 349660

Date Posted: 04/23/2026

Shortcut: http://jobs.systemone.com/nXPGCJ


Job Title: Drug Safety Associate III 349660
Location: Pharma in Stamford, Connecticut
Type: 12-month Contract
Compensation: up to $35/hour (dependent on experience)
Work Model: Remote with some travel during inspections
Hours: 8am to 4pm or 9am to 5pm Mon-Fri


Responsibilities

  • Perform case processing activities (triage, data entry, report distribution) as required.
  • Assess, process, and data enter all AE case types to meet compliance requirements.
  • Perform triage on all case types to determine prioritization.
  • Identify adverse events, seriousness, and listedness/labeledness for case assessment; review additional incoming information to determine reportability.
  • Perform all appropriate coding reviews using MedDRA, WHO-DRUG, and Company Product dictionaries.
  • Own case narrative - create narrative text as required for medical orientation.
  • Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information.
  • Perform CRO case QC activities, reconciliation as required.
  • Work on highest priority or assigned cases using Workflow Management System, or as directed.
  • Participate in inspections and audits as identified, including interviews and provision of requested data.
  • Meet KPIs/KQIs as designated by company and in compliance with company guidelines and policies.
  • Assist in writing late ICSR related deviations and CAPAs, upon request.
  • Perform additional tasks as assigned.
  • Work independently, assess matters, propose resolutions, and appropriately escalate internally within company organization.
  • Prepare monthly QC metrics and distribute among the team.
  • Active Participation in Inspection readiness work and respond to FDA queries.
  • Perform vendor management activities like coordinating with vendors on ICSR QC activities and voice call QC activities as needed.

Requirements
  • Bachelor’s degree (advanced degree preferred) in life science or healthcare (e.g., nursing, pharmacy)
  • Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company
  • Minimum 3 years in Drug Safety Operations role; Experience overseeing CRO teams of case processors preferred
  • US FDA pharmacovigilance inspection experience preferred
  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding skills
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability – takes ownership of deliverables
  • Ability to work independently and assess matters critically



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