What are the responsibilities and job description for the Drug Safety Associate position at Zenith LifeScience?
Location: Stamford, CT (Fully remote and onsite required during Inspections)
Duration: 12 Months
Job Description
Duration: 12 Months
Job Description
- 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 (if requested by Company)
- Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability
- Select the appropriate as reported causality and company causality
- Perform all appropriate coding 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 etc as required.
- Work on highest priority or assigned cases using Workflow Management System, or as directed
- Support PV inspections and audits as identified, including interviews and provision of requested data
- Monitor vendor KPIs/KQIs as designated by Company and in compliance with company guidelines and policies
- Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Company organization
- Bachelors 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
- Considers present and future impacts when making recommendations
- Strong negotiation and problem-solving skills
- Analytical skills and attention to detail
- Accountability takes ownership of deliverables