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!
Services
Process & Improvement
- Clinical Safety & PV SOPs, Policy, & WI Generation & Review
- PSMF & RMP Implementation, Support, Templates, Gap Analysis
- Organizational Structure Support (Job descriptions, functional development)
- SAERF & Pregnancy Report Form Templates
- PV Agreements
- Protocol & IB Review
- REMS Implementation and Audits
- Signal Detection & Risk Management
- Case processing & Medical review
- Aggregate Safety Reports Generation & Review (PADER, PBRER, PSUR, DSUR, etc.)
- GVP Audits and Risked Based Audit Strategy Approach
- GVP Vendor Selection, Management, and Support
- GVP Regulatory Review & Information
- GVP Inspection Readiness and execution
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
Quality & Compliance
- GVP 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
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 a global PV community, I have 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!
