What are the responsibilities and job description for the Drug Safety Operations Associate position at Katalyst Healthcares & Life Sciences?
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 (if requested by Client).
- 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.
- Support ICSR submissions and transmissions as needed.
- Perform CRO case QC activities, reconciliation etc 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 Client 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 Client organization.
- 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.
- 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.
