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.
Pharmacovigilance System Master File (PSMF)
This template meets the specifications of the new EU pharmacovigilance legislation.
SOPs
These standard operating procedures have passed US and EU regulatory inspections.
Forms
These are forms that are used together with the SOPs to document case processing and other activities.
Safety Data Exchange Agreement Template
This template can be used for all SDEAs between your company and others in the industry.
PSUR Writing Manual
This writing manual can help you prepare an E2C-compliant periodic safety update report.
Dashboard Metrics
We created a document containing the metrics that need to be collected in various categories such as case and report volume, effort per case, and average cycle time.
Training Material
This template can be used for all SDEAs between your company and others in the industry.
Global AE Process Flow Diagrams
This writing manual can help you prepare an E2C-compliant periodic safety update report.
Roles, Job Descriptions, and Skills Requirements Matrix
This matrix contains the definitions of roles and jobs as well as the needed skills for all drug safety and pharmacovigilance staff members.
PSUR Checklist
This checklist supports the PSUR review.
PSUR and PADER Scorecards
We created Excel spreadsheets that are to be used as PSUR and PADER quality scorecards.
PV Audit Checklist
The PV Audit Checklist is designed to help you see if you meet drug safety laws, regulations, and guidance.