Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Kristin Lione

Fitchburg

Summary

Senior medical professional with over 20 years of clinical and therapeutic expertise in medical monitoring, pharmacovigilance, and regulatory filings. Proven track record in CRO, Pharma, and Biotech sectors, contributing to global safety services and clinical informatics with a focus on immunology, oncology, CNS, and psychiatry. Skilled in ensuring compliance in regulatory submissions and enhancing patient safety through collaboration with multidisciplinary teams. Committed to driving clinical development excellence and navigating Phase I-III trials to support impactful healthcare innovations.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Medical Director-Medical Monitor

IQVIA
Durham
05.2022 - 04.2025
  • Functioned as Global Medical Advisor overseeing clinical trials Phase I-III. Advised project leaders on critical medical and scientific considerations throughout project lifecycle.
    Assisted investigative sites with protocol queries, inclusion/exclusion criteria, and safety concerns.
    Performed thorough reviews of protocols, drug brochures, study reports, and patient narratives.
    Engaged in bid defense efforts and contractual agreements for Medical Monitoring services.

Medical Director-Pharmacovigilance

IQVIA
Durham
01.2010 - 05.2022
  • Conducted medical reviews of trial-related adverse events and post-marketing drug reactions. Performed signal detection and analysis to identify potential safety issues. Presented safety and clinical data review findings during client meetings. Reviewed regulatory safety and risk management reports for compliance and accuracy. Provided medical oversight for label development, revisions, and updates.
    Supported data safety monitoring board meetings with expert medical input.

Medical Director-Post Approval Drug Safety/Risk Management Officer

PPD, INC
Morrisville
05.2007 - 01.2010
  • Conducted medical reviews of individual case safety reports.
    Authored pharmacovigilance signal and trend analysis reports.
    Compiled regulatory aggregate reports to ensure compliance.
    Developed clinical development plans to guide research initiatives.
    Produced business development white papers to support strategic decisions.

Drug Safety Physician

UCB Pharma
Atlanta
03.2004 - 01.2010
  • Led safety initiatives for CNS and immunology products, focusing on epilepsy, pain, and antibody therapies. Supervised clinical studies covering Phase I through IV, ensuring adherence to regulatory standards. Managed investigator-initiated trials to generate additional evidence-based insights. Administered compassionate use protocols for patients requiring immediate interventions. Conducted pediatric trials to ensure age-appropriate safety assessments. Evaluated pregnancy registry results to identify any adverse effects during pregnancy.

Education

M.D. - GME OB/GYN, Surgery, Womens Health

Emory University
Atlanta, GA
07-2003

M.D. - Medicine

University of Wisconsin-School of Medicine
Madison, WI
05-2000

Associate of Science - Pharmacology And Toxicology

University of Wisconsin-School of Pharmacy
Madison, WI
05-1990

Skills

  • Clinical trial management
  • Safety signal detection
  • Regulatory compliance
  • Risk assessment
  • Medical evaluation
  • Data analysis

Certification

  • National Board of Medical Examiners (USMLE 1, 2, 3):1998, 2000, 2001.

Timeline

Medical Director-Medical Monitor

IQVIA
05.2022 - 04.2025

Medical Director-Pharmacovigilance

IQVIA
01.2010 - 05.2022

Medical Director-Post Approval Drug Safety/Risk Management Officer

PPD, INC
05.2007 - 01.2010

Drug Safety Physician

UCB Pharma
03.2004 - 01.2010

M.D. - GME OB/GYN, Surgery, Womens Health

Emory University

M.D. - Medicine

University of Wisconsin-School of Medicine

Associate of Science - Pharmacology And Toxicology

University of Wisconsin-School of Pharmacy

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