Pharmacovigilance Products


A comprehensive global pharmacovigilance system is within your reach with help from SJ Pharma Consulting, LLC in Mendham, NJ. We can supply you with an array of PV products that can aid in improving your company's operations.
 
An Overview of Our Main Deliverables
 
 
This template meets the specifications of the new EU pharmacovigilance legislation.
 
These standard operating procedures have passed US and EU regulatory inspections.
 
These are forms that are used together with the SOPs to document case processing and other activities.
 
 
This template can be used for all SDEAs between your company and others in the industry.
 
This writing manual can help you prepare an E2C-compliant periodic safety update report.
 
We created a document containing the metrics that needs to be collected in various categories such as case and report volume, effort per case, and average cycle time.
 
 
We offer a course that covers the basics of pharmacovigilance, global regulatory requirements, audits, signaling and risk assessment, and communication of safety issues.
 
Our Visio flowcharts show the duties and responsibilities required of drug safety and pharmacovigilance operations.
 
This matrix contains the definitions of roles and jobs as well as the needed skills for all drug safety and pharmacovigilance staff members.
 
 
This checklist supports the PSUR review.
 
We created Excel spreadsheets that are to be used as PSUR and PADER quality scorecards.
 
The PV Audit Checklist is designed to help you see if you meet drug safety laws, regulations, and guidance.