Drug Safety Operations Associate Job at Katalyst HealthCares and Life Sciences, Stamford, CT

cks1QVR2dVp4TkpJc09icDc3c0VKc1VRT1E9PQ==
  • Katalyst HealthCares and Life Sciences
  • Stamford, CT

Job Description

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 Client).
  • 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 Client 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 Client organization.

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.
  • US FDA pharmacovigilance inspection experience preferred.

Skills:

  • Resource and workflow management (monitoring and assigning tasks).
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding.
  • Considers present and future impacts when making recommendations.
  • Strong negotiation and problem-solving skills.
  • Analytical skills and attention to detail.
  • Accountability - takes ownership of deliverables.

Job Tags

Full time,

Similar Jobs

Fox Point Recruitment LLC

Bankruptcy Attorney -Philadelphia, PA, US Job at Fox Point Recruitment LLC

 ...environment while gaining valuable experience. The Associate Attorney is responsible for handling bankruptcy matters for the firm....  ...behalf of our clients. Location :Onsite, Philadelphia, PA, US Salary : To be discussed with a Fox Point Representative (... 

PowerFlex

Associate Director - Solar Operations Job at PowerFlex

 ...reduce cost and maximize return on investment. Our technology is deployed at scale to prominent commercial customers such as Adobe, DHL, Prologis, Target, and municipalities such as County of LA. PowerFlex is a top 5 provider in each of Commercial Solar, Storage and EV... 

Ameritech Windows

Show Model Job at Ameritech Windows

 ...WEEKEND GIG WITH BIG ENERGY Are you outgoing, confident, and love being the face of something big? Were looking for Show Models to represent a leading construction company at weekend trade shows. As a Show Model, Youll No hard hats required just your... 

CJI Piping and Fabrication

Assistant Project Manager Job at CJI Piping and Fabrication

 ...Overview: Reports to: Principal, Project Manager, or Project Executive FLSA Status: Full-Time, Salaried-Exempt Normal Working Hours...  ...completing project duties. Position Objective: Responsible for assisting the project team with project administration, scheduling,... 

PPS-HPS

Fitter/Welder Job at PPS-HPS

 ...opportunity in Olmsted Falls, OH. The welder fitter will lay out, fit, and fabricate metal components to assemble handrails using MIG Welding principles Primarily Flux core Fitting Experience 5 years structural steel/fab shop Mechanical Aptitude...