Summary
Overview
Work History
Education
Skills
Websites
Professional Development
Hobbies and Interests
Timeline
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Tracy Edwards

Tracy Edwards

Garner,NC

Summary

Accomplished Risk Leader with a Focus on Pharmaceutical and Biotechnology Industries, Seeking to Leverage Expertise in a Legal Setting

I am an accomplished Risk Management professional with extensive analytical and quality assurance experience in the pharmaceutical and biotechnology sectors. I am known for conducting thorough risk analyses and implementing robust risk management frameworks, as well as managing data strategy projects to achieve key company initiatives.

As a Strategic Risk Manager, I have a proven track record of delivering highly productive and efficient task completion. My expertise includes risk assessment, regulatory compliance, and financial forecasting, ensuring comprehensive management of uncertainties.

I excel in critical thinking, problem-solving, and communication, which I leverage to navigate complex challenges and drive effective decision-making processes. I am eager to bring my skills and experience to a law firm, where I can contribute to the firm's success by applying my risk management expertise in a legal context.

Overview

8
8
years of professional experience

Work History

Quality Risk Manager

ProSCIENTO
Chula Vista
11.2023 - Current

Manager, Pharmacovigilance (PV) Risk Management

JOHNSON & JOHNSON
Titusville
06.2021 - 02.2023

Manager, Quality Risk Management

NOVARTIS GENE THERAPIES
Durham
05.2020 - 06.2021

Consultant, Quality Systems

PFIZER (FORMERLY GLOBAL BLOOD THERAPEUTICS)
South San Francisco
07.2019 - 01.2020

Manager, Operational Risk Management

PAREXEL
Durham
12.2016 - 07.2019

Education

Master of Management, Risk and Analytics -

NORTH CAROLINA STATE UNIVERSITY, POOLE COLLEGE OF MANAGEMENT
Raleigh, NC
05.2025

Bachelor of Science (BS), Chemistry and Textile Chemistry -

NORTH CAROLINA STATE UNIVERSITY, COLLEGE OF SCIENCES
Raleigh, NC

Skills

  • Risk Management
  • Continuous Process Improvement
  • Critical Thinking
  • Regulatory Compliance
  • Frameworks
  • Analytical Thinking
  • Risk Governance Policy
  • Key Risk Indicators (KRIs)
  • Legal writing
  • Intellectual Property Law
  • Conflict Resolution
  • Communications Drafting
  • Attention to Detail
  • Corporate Law
  • Key Performance Indicators (KPIs)
  • Professionalism
  • Legal Interpretation and Adaptation

Professional Development

  • Risk Essential Masterclass, Institute of Risk Management, 03/01/22
  • FPX (Flawless Project Execution), 11/01/21
  • Project Manager/ Core Team Member for Data Strategy Project in Pharmacovigilance Risk Management, 12/01/99
  • Clinical Research Core Competencies Certificate, 12/01/99
  • Medical Product Safety and Pharmacovigilance Certificate, 12/01/99

Hobbies and Interests

Mentoring/Coaching, Volunteering, Risk/Business Analytics, Data Visualization, Data Law, Enterprise Risk Management, Intellectual Property, Patent Law

Timeline

Quality Risk Manager

ProSCIENTO
11.2023 - Current

Manager, Pharmacovigilance (PV) Risk Management

JOHNSON & JOHNSON
06.2021 - 02.2023

Manager, Quality Risk Management

NOVARTIS GENE THERAPIES
05.2020 - 06.2021

Consultant, Quality Systems

PFIZER (FORMERLY GLOBAL BLOOD THERAPEUTICS)
07.2019 - 01.2020

Manager, Operational Risk Management

PAREXEL
12.2016 - 07.2019

Master of Management, Risk and Analytics -

NORTH CAROLINA STATE UNIVERSITY, POOLE COLLEGE OF MANAGEMENT

Bachelor of Science (BS), Chemistry and Textile Chemistry -

NORTH CAROLINA STATE UNIVERSITY, COLLEGE OF SCIENCES
Tracy Edwards