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Junetta Irvine

Project Manager, Pharmacovigilance and Drug Safety Services

Employment History

May 2013Present

Project Manager, Pharmacovigilance and Drug Safety Services

Covance - Nashville, TN location
  • Provide leadership and management of global and regional clinical projects ensuring that communications and processes are harmonized
  • Monitor and oversee workflow of projects to ensure all deadlines are met and compliant in accordance with the International reporting regulations, Standard Operating Procedures and internal departmental safety processing guidelines
  • Work collaboratively with the data management, clinical operations and project management teams to ensure PV&DSS activities are performed according to the contractual requirements
  • Provide oversight of the receipt and processing of adverse event reports from safety database entry - ARGUS, AERS, ARISg, IRT, EDC, Oracle Clinical; code adverse events using MedDRA, determine expectedness/listedness based on IB
  • Provide support and training in all aspects of case processing and other safety functions
  • Attend and present at client and team meetings - Investigator's Meetings, Face-to-Face meetings, Departmental Overview, Bid Defenses
  • Generation of monthly status and other project-specific reports; adherence of contract and budget obligations by analysis of safety cost and billing trends and out of scope activities
Mar 2009May 2013

Senior Drug Safety Associate

Covance
  • Management of the planning and setting up of projects as assigned by manager - generation, review and updating of the study project plans
  • Set-up and maintenance of the safety trial master files
  • Development of templates and tools for project team members
  • Processing of full scope and reduced service safety reports
  • Provide peer QC for client deliverables prior to submission to the client
  • Prepare letters for expedited safety reports
  • Perform SAE reconciliation in collaboration with the data management team
  • Work closely with study monitors and study sites in closing out safety queries
Sep 2006Mar 2009

Drug Safety Associate

Covance
  • Assist in the set up of projects as assigned by management
  • Case processing  - entry of safety data into safety databases and tracking systems; review safety report from site for completeness and accuracy; write patient narratives; code adverse event terms; generation of queries; collaborate with Medical Monitor on safety report;
  • Prepare departmental meeting minutes
  • Answer safety hotline calls
Sep 2003Sep 2006

Clinical Research Assistant

Covance
  • Direct study contact for project team and study sites for supplies, questions and assistance
  • Create, update, track and maintain study-specific trial management files, tools and systems for study team
  • Assist the local project team members with other administrative activities as needed
  • Proficiency in Microsoft applications

Aug 2002Sep 2003

Clinical Data Coordinator I

Covance
  • Review clinical trial data in accordance with data review conventions to identify erroneous, missing, incomplete or implausible data
  • Write, program and validate diagnostics
  • Annotation of CRF
  • Proficient in Oracle Clinical and EDC
Jun 2001Aug 2002

Clinical Data Associate

Covance
  • Carry out query production, resolutions, and tracking to resolve problematic data identified during review of CRF
  • Assist with the set up of study files and the collection, filing, transfer and archiving of study documentation and controlled documents

Education

19931998

Bachelor of Science

Western Kentucky University

Public Health / Community Health

Therapeutic Experience

  • Oncology
  • Renal Disease
  • Cardiovascular
  • Skin Infections
  • Psoriasis
  • Hepatitis C
  • Dyslipidemia
  • Opioid Induced Bowel Dysfunction
  • Pulmonary Embolism
  • Childhood vaccinations