Job Description

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

• 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

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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