Drug Safety Operations Associate Job at Morph Enterprise, Stamford, CT

T2VWLzIyREdwRWs2SHFHYWRVZjg4NjBQQmc9PQ==
  • Morph Enterprise
  • Stamford, CT

Job Description

Job Description

Job Description

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 (if requested by Purdue)
    • 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 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 Purdue organization

Job Tags

Similar Jobs

Milton Hershey School

Track and Field Middle School Assistant Coach Job at Milton Hershey School

 ...all Careers JOB ID: 25000022 Hershey, PA Part-time Job Category: Ancillary (Lifeguards/Summer/Seasonal) Milton Hershey School (MHS) is a top-notch home and school where 2,100 pre-K through 12th grade students from disadvantaged backgrounds are provided with... 

Pool Scouts of the VB/Norfolk Area

Swimming Pool Cleaner Job at Pool Scouts of the VB/Norfolk Area

 ...Job Description Job Description Pool Scouts of Virginia Beach and Norfolk is looking to hire motivated and hard-working individuals...  ...is required. We'll train you to service our customers' swimming pools if you're trustworthy and reliable. Part-time and full-time... 

Office Depot, Inc.

Forklift Operator Job at Office Depot, Inc.

 ...powered lifting equipment to move product throughout the facility. May operate stock picker, sit down/stand up equipment, reach truck, etc. - Contribute to a safe work environme Forklift Operator, Lift Operator, Forklift, Operator, Manufacturing, Retail Office Depot, Inc.

Management Recruiters of Arkansas

Process Engineer Job at Management Recruiters of Arkansas

 ...PROCESS ENGINEER (Plastic Injection Molding) Benton, AR Our client has an excellent work-life culture, great benefits and location (low cost of living area, high quality of life, great outdoor activities or metropolitan entertainment just minutes away). In addition...