Drug Safety Associate III

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.
  

• 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