Job Description

Duties:

Drug Safety Associate at Purdue

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
Purdue)

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 Purdue 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.

Meet Your Recruiter

Salma Sulthana

Job Tags

Full time

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