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Global Executive PV Consultant

Dedicated to providing Clinical Safety & Pharmacovigilance expertise and services

Welcome

Are you looking for someone to help grow, enhance, or manage your clinical safety or Pharmacovigilance (PV) capabilities? I am the Principal Consultant and owner of Essential Pharmacovigilance, LLC and would be happy to engage with you about your needs. 


When I decided to go into consulting, I wanted to develop a name that would exemplify my mission and career goals, which is to provide pharmaocviilance services which are essential to the activities which ensure the products developed are safe and effective for the public. Thus was born "Essential Pharmacovigilance". 


From Departmental development and GVP Training, to Inspection Readiness and PV Post marketing activities, I aim to provide my partners with exceptional services of the highest quality!

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Services

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Process & Improvement

 - Clinical Safety & PV SOPs, Policy, & WI Generation & Review

 - PSMF Support, Templates, Gap Analysis 

- Organizational Structure Support (Job descriptions, functional development)

- SAERF & Pregnancy Report Form Templates

- PV Agreements

- Protocol & IB Review

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Clinical Safety & PV Training

- Training Matrixes, curriculum review & development for Safety & PV Professionals


Topic Specific & Tailored Training - In person or Remote

- PSMF Management

- Developing a compliant PV Quality Management System

- GVP Training

- ICSR & Safety Narrative writing

- QC Principles & Practices

- Generating and Tracking Safety Letters & Effective communication

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Quality & Compliance

- Auditing support, audit report & CAPA Plan templates and management

- PV Inspection Readiness & Training, Front & Backroom support and management

- GVP Annual and Strategic Plans with Risk-based Assessment strategies

- Compliance Metrics & strategies


Other

- Slide development for Safety Training on Adverse Event Reporting

- General Slide development for PV, Medical Information, and Medical Communications topics

About

Catherine Baldridge, MS, Principal Consultant, Owner

Located in Virginia, US, I have been in the Pharmaceutical industry for 15 years, helping companies with product development both pre- and post-market, focusing on clinical safety, PV & compliance activities. 


Along with my strong industry experience, I have a background in Psychology & neurological testing. To further support my interests in public health, I completed by Masters of Science degree in Health Evaluation Sciences, focusing on Clinical Investigation and Patient Oriented Research from the University of Virginia. 

My Mission

My mission is to provide expert consultancy, training, and services for companies who need assistance with their Clinical Safety & Pharmacovigilance activities. 


I aim to provide meaningful relationships with colleagues and clients, focusing on cross-functional engagement in order to promote a holistic approach to the monitoring and review of product safety, no matter what the stage (in development or already marketed).  

Why?

Why me? Work with someone who is enthusiastic and dedicated to developing and enhancing Safety & PV Professionals and Processes! 


I'll be upfront and transparent about services and capabilities to ensure our mutual partnership is not only effective but rewarding!

Global Experience

Global Expertise

Although based in the US, I have extensive experience in global regions relating to safety & regulatory requirements. Primarily can serve as a resource for US, Canada, EEA, South Africa, Australia and others. 


Additionally, being a part of the DIA Program Committee for their annual PV & RIsk Management Strategies conference and having served previously as Chair of the Clinical Safety & PV Community through DIA, has awarded me the privilege to engage with regulators and key opinion leaders, as well as gain access to current and innovative insights and practices as they relate to this topic area. If I'm unable to help you, I'm sure I'll know someone else who can!



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Contact

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Essential Pharmacovigilance

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