Drug Safety Associate III
Stamford, Connecticut
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Remote
Brand: Joulé
Job ID: 349660
Date Posted: 04/23/2026
Shortcut: http://jobs.systemone.com/Ir5geq
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
Ref: #558-Scientific
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