Clinical Trial Consultant II jobs in United States
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Planet Pharma · 14 hours ago

Clinical Trial Consultant II

positionUnited States
timeFull-time
remoteRemote
seniorityMid, Senior Level
money$50/hr - $60/hr
date4+ years exp

Planet Pharma is an organization focused on clinical trial consulting, and they are seeking a Clinical Trial Consultant II. The role involves case processing and quality control of clinical trial ICSRs and postmarket case processing, ensuring timely delivery and compliance with regulatory reporting.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases
Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
Perform retrospective quality checks on processed cases
Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
Provide investigation details into late regulatory reporting of CT cases

Qualification

ICSR processingGlobal safety regulationsPharmacovigilanceSafety database systemsMedical terminologyMicrosoft OfficeWritten communicationVerbal communication

Required

Knowledge of Global and local safety regulations
Excellent written and verbal communication skills
Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
Education: Bachelors degree in science or healthcare related field
Experience: 4+ years experience in pharmacovigilance

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.
dateFounded in 2009
location
Northbrook, Illinois, USA
people-size1001-5000 employees
web-link
http://planet-pharma.com

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase