Drug Safety Operations Associate - Katalyst Healthcares & Life Sciences

South Plainfield, NJ 07080

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 listed / labelled 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.
Support ICSR submissions and transmissions as needed.
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.

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).

Source : Katalyst Healthcares & Life Sciences