pharmacovigilance consulting services with sj pharma consulting

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Pharmacovigilance Consulting Services with SJ Pharma Consulting

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Page 1: Pharmacovigilance Consulting Services with SJ Pharma Consulting

Pharmacovigilance Consulting Services

with SJ Pharma Consulting

Page 2: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 3: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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

Page 4: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 5: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 6: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 7: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 8: Pharmacovigilance Consulting Services with SJ Pharma Consulting

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.

Page 9: Pharmacovigilance Consulting Services with SJ Pharma Consulting

Learn More

For more information about our drug safety and pharmacovigilance compliance consulting services, visit us

online at SJPharmaCo.com.