SJ Pharma Consulting is a world leader in global pharmacovigilance compliance and drug safety with over 30 years of experience. They offer pharmacovigilance auditing, European pharmacovigilance compliance services, signaling and data mining solutions, and both in-person and online pharmacovigilance and drug safety training courses to help clients maintain compliance with US and EU regulations. Their services help companies introduce new products efficiently while ensuring their pharmacovigilance operations meet all applicable laws and regulations.

1. Pharmacovigilance
Consulting Services
with SJ Pharma Consulting

2. SJ Pharma Consulting Inc. is a world leader in global
pharmacovigilance compliance and drug safety. Our
pharmacovigilance experts have more than three decades
of experience in the industry and serve over 200 clients
across the U.S., Europe, Japan, China and India. Through
our industry-leading services, we help pharmacovigilance
operations maintain compliance with the latest US and EU
laws and regulations.

3. What can SJ Pharma Consulting do for you?
Our drug safety & pharmacovigilance compliance consulting
services include:
• Pharmacovigilance (PV) audit
• European pharmacovigilance
• Signaling
• Pharmacovigilance & drug safety training courses

4. Pharmacovigilance (PV) Audit
Since our founding in 2001, SJ Pharma has conducted over 100 safety audits and
assessments. Using our 50-page audit checklist, we evaluate your operations in
terms of strategy, organizational structure, quality processes, SOPs, and systems
and PV risk management. Our audits benefit you in the following ways:
• Ensures your company's pharmacovigilance operations comply with
applicable laws, regulations and guidances.
• Provides a comparison of the best practices of similar organizations.
Learn more about our pharmacovigilance (PV) audit services here.

5. European Pharmacovigilance
At SJ Pharma, we help companies set up and maintain fully functioning
pharmacovigilance systems that comply with the latest EU PV regulatory
requirements, as well as provide training in every area of European
pharmacovigilance and drug safety compliance. Through our services, your
company can introduce new products efficiently, while maintaining a clear
understanding of the follow up process.
Learn more about our European pharmacovigilance services here.

6. Signaling
SJ Pharma offers a comprehensive signaling and data mining/visualization
solution for life science companies of all sizes. We can assist you in the following
areas:
• Defining your requirements for signaling.
• Selecting and implementing the appropriate software.
• Developing processes and SOPs that are compliant with US and EU laws and
regulations.
Learn more about our signaling services here.

7. Pharmacovigilance & Drug Safety
Training Courses
At SJ Pharma, we provide a variety of drug safety and pharmacovigilance training
courses that address US, EU and ICH regulatory requirements. We offer courses
online and in-person. Here are some of our current course offerings.
In-person training:
• Introduction to Drug Safety: US and EU Requirements
• The Pharmacovigilance Audit: How to Prepare for an Inspection
• Signal Detection and Pharmacovigilance
Sign up for in-person pharmacovigilance & drug safety training courses here.

8. Pharmacovigilance & Drug Safety
Training Courses
Online training:
• Essentials of Drug Safety:
• Global Regulatory Requirements for Pharmacovigilance
• The Pharmacovigilance Audit
• Signaling & Risk Management
• Device Safety and Vigilance
Sign up for online pharmacovigilance & drug safety training courses here.

9. Learn More
For more information about our drug safety and
pharmacovigilance compliance consulting services, visit us
online at SJPharmaCo.com.