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

LifeBridge Health

INPATIENT SOCIAL WORKER LMSW Job at LifeBridge Health

 ...INPATIENT SOCIAL WORKER LMSW ~Sign On Bonus Potential: up to $15,000 ~ Randallstown, MD ~NORTHWEST HOSPITAL ~NW CARE MANAGEMENT ~Full-time w/Weekend Commitment - Day/Evening Shift - 8:30am-7:00pm ~Allied Health ~87808 ~$28.00-$49.00 Experience... 

Mom's Meals, a PurFoods Company

3rd Shift Sanitation Associate Job at Mom's Meals, a PurFoods Company

Position Summary The Sanitation Associate will clean facility and equipment to meet internal Sanitation Standard Operating Procedures (SSOP) and ensure FDA & USDA standards. The primary focus is doing a deep clean on machines to ensure they pass pre-op inspection each...

EYA

Marketing Intern Job at EYA

 ...award winning residential builder/developer, is seeking a Marketing Intern to develop and maintain marketing and digital content. This...  ...Currently pursuing a degree in Marketing, Communications, Graphic Design, English, Journalism, or a related field. ~ Tech-savvy, with... 

Idaho State Job Bank

Sr. Hogan Developer (CIS/PAS) (Remote/Hybrid) Job at Idaho State Job Bank

Sr. Hogan Developer (CIS/PAS) (Remote/Hybrid) at UMB Bank in Boise, Idaho, United States Job Description The Hogan Development team is comprised of application developers and architects providing support of our Core Deposits and Customer systems (also known as Hogan Systems... 

HirefinderRPO

3D Digital Artist Job at HirefinderRPO

 ...work environment and pride ourselves on the supportive atmosphere we have worked hard to promote. Position Summary As a 3D digital artist at our company, you'll be one of the fundamental creative driving forces behind our product designs, marketing material, and...