Drug Safety Operations Associate - Cogent Infotech Corporation

Remote, CT 06901

Assignment Description:
JOB SUMMARY

Position performs adverse event processing responsibilities supporting the Case Management function within Drug Safety Operations.

Primary 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
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
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 organization

Education and Experience 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
FDA pharmacovigilance inspection experience preferred

Necessary Knowledge, Skills, and Abilities

Source : Cogent Infotech Corporation