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

bkIzUXJMTmdMWTQ2MDE1VWZjc1dlaEQzSUE9PQ==
  • Morph Enterprise
  • Stamford, CT

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

TRC Talent Solutions

Composite Manufacturing Supervisor Job at TRC Talent Solutions

 ...TRC is seeking a Manufacturing Supervisor for one of our aerospace and aviation clients for an onsite role based out of San Jose, CA! Role Overview: As the Aerospace Composite Manufacturing Supervisor, you will lead a team of skilled composite structure technicians... 

Apple Inc.

SoC Physical Design Engineer Job at Apple Inc.

 ...Description - Work multi-functionally with CAD/Physical Verification/Electrical analysis and PnrR...  ...teams for node evaluations, global PD engineers, and physical verification and electrical analysis teams.- Resolve design and flow issues related to physical design,... 

Uber

Flexible Gig - Drive with Uber Job at Uber

 ...What is Uber? Driving with Uber is an alternative to a part-time or full-time job and can get you earning cash on the road quickly. Driving with Uber allows you to earn quick cash while maintaining the flexibility your schedule requires (gig, part-time, full-time, seasonal... 

Raytheon

Netherlands Patriot Chief Engineer/Technical Director - (P5 - Senior Principal Systems Engineer - Onsite - Tewksbury) Job at Raytheon

 ...MA134: Innovation Dr Tewks Bdg 400 836 North Street Building 400, Tewksbury, MA, 01876 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling to help our nation and allies defend freedoms and... 

LifeStance Health

Psychiatric Nurse Practitioner (PMHNP) - Outpatient -Child Focus Job at LifeStance Health

 .... Interested in growing professionally. What we offer Nurse Practitioners: ~100% Outpatient work in a Group Practice Setting. ~ Generous...  ...at its clinics nationwide and through its digital health telemedicine offering. The company employs psychiatrists, psychologists,...