Junetta Irvine

  • 1032 Marilee Court Orlinda TN

Project Manager, Pharmacovigilance and Drug Safety Services

Employment History

Work History
May 2013 - Present

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 2009 - May 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 2006 - Mar 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 2003 - Sep 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 2002 - Sep 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 2001 - Aug 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

Education
1993 - 1998

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