Certara’s Pharmacovigilance (PV) writing services are designed to integrate seamlessly into your drug development process, ensuring compliance with global regulatory requirements while prioritizing patient safety. From patient narrative authoring to risk management plans, our team of experts delivers end-to-end solutions powered by cutting-edge technology. By leveraging CoAuthor’s technology-enabled authoring, we streamline the creation of critical safety-related documents, maintaining accuracy and consistency across the board.
Safety and Pharmacovigilance
Ensure patient safety
with comprehensive expertise in safety and pharmacovigilance
Learn more about Certara’s pharmacovigilance writing
Ensuring compliance and patient safety across the drug lifecycle
Integrated expertise
Certara offers a unified team of pharmacovigilance experts, reducing hand-offs and ensuring seamless project execution.
Technology-driven efficiency
Utilize CoAuthor’s advanced capabilities to expedite narrative writing process while maintaining quality.
Global compliance assurance
Our in-depth regulatory knowledge ensures adherence to guidelines across major global agencies.
Customized solutions
Flexible processes tailored to meet changing regulatory requirements and project timelines.
Innovating pharmacovigilance with expertise and technology
Our offerings
CoAuthor software
Streamlined safety narrative authoring.
Regulatory market access
Ensure regulatory compliance and market readiness.
Safety analysis reports
Comprehensive safety data analysis.
Every stage of drug development
From risk management plans to DSURs and safety signal evaluations, Certara delivers accurate, timely, and compliant documentation.
Meet our experts
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Experts
Chris Bouton, PhD
Senior Vice President & Head of AI
Chris has spent his entire career leveraging cutting edge analytics capabilities to help the life sciences industry solve challenging data problems.
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Experts
Reema Selvaraju
Associate Director, Patient Safety Narratives and Automation
Reema SelvaRaju is a trained microbiologist with over 15 years of expertise in regulatory writing, specializing in pharmacovigilance narratives and clinical study reports (CSR narratives). She also has extensive experience in project management and leveraging automation technology.
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Experts
Ragini Hari
Senior Director of Statistics
Ragini is a trailblazer in the pharmaceutical industry, bringing over 20 years of expertise in statistical programming, biometrics, and data management.
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Certara’s pharmacovigilance writing experts are here to guide you through every phase of your safety document needs. Let us help you ensure compliance, improve efficiency, and secure patient safety with our innovative solutions.
Why Contact Certara?
Expertise in global safety standards and regulatory compliance.
Proven success in delivering high-quality safety documents.
Technology-driven solutions for faster, consistent results.
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FAQs
What is pharmacovigilance (PV) writing, and why is it important?
Pharmacovigilance writing involves expert guidance to ensure drug safety and compliance with regulatory standards, minimizing risks and safeguarding patient health.
How does Certara support pharmacovigilance (PV)?
Certara offers integrated teams, advanced technology, and regulatory expertise to streamline safety processes and ensure compliance.
What is CoAuthor, and how does it improve narrative authoring?
CoAuthor is a technology-enabled platform that accelerates and improves the consistency of safety narrative creation for regulatory submissions.
