1. Industries title Industry & Digital Expertise | Cognizant
  2. Life Sciences title Life Sciences Technology Solutions | Cognizant
Pharmacovigilance
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PHARMACOVIGILANCE SERVICES

Ensure patient safety with pharmacovigilance services

Cognizant is a global, single-source pharmacovigilance (PV) full service provider (FSP) that safeguards and elevates pharmaceutical products.
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<h3>Transform pharmacovigilance complexity into game-changing opportunities</h3> <h5>As the pace of pharmaceutical drug delivery speeds up, ensuring patient safety and meeting regulatory demands, changing reporting requirements, managing rising costs and handling vast data sources is crucial.<br> </h5> <h5>Pharma/biotech organizations face incredible challenges when bringing new products to market and require simplicity, standardization with high-quality outcomes and compliance for their PV processes.</h5> <h5>At Cognizant, we simplify PV. Our FSP processes and technology help you stay compliant and reduce risks. We believe in transparent partnership, simplified governance and managing costs, so you can focus on innovation.</h5>
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<h3>Business outcomes and strong ROI</h3> <p>Some of the results we've delivered</p>

4M+

AE case versions processed annually

8,000+

safety reports authored annually

700K+

local affiliate AE cases

3,128+

annual product reports

~250

products for safety risk management strategy

10K+

literature articles reviewed annually

20+

global delivery locations

12+

therapeutic areas of expertise

6,000+

products managed annually

80%

reduction in migration time using our accelerators

4.57

average customer satisfaction survey results

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WHAT SETS US APART
<h3>Cognizant pharmacovigilance services</h3> <p>Our team of experts combine extensive industry knowledge with technical expertise along with advanced AI, automation and cloud-based PV technologies to develop customized, human-centered solutions. From data collection, detection, and assessment to comprehension and oversight, our solutions ensure that your safety profile remains up to date and compliant, offering the flexibility and transparency you require. With a track record of delivering world-class results, and a comprehensive partner network, we are devoted to upholding excellence and patient safety while supporting your product releases.</p>
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Pharmacovigilance consulting
Pharmacovigilance consulting

Leveraging our extensive PV lifecycle experience, we assess your processes, technology and resources to transform your PV, from submission strategies and selecting the best safety database to developing KPIs and managing change.

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AI- driven Pharmacovigilance digital platform
AI- driven Pharmacovigilance digital platform

Harness AI with Cognizant’s PV platform, featuring smart tools for intake, literature search, signal management and PV-IT services to boost efficiency and freeing your teams to focus on critical decision-making.

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Pharmacovigilance operations
Pharmacovigilance operations

Our flexible, cost-effective, AI and automation powered solutions provide a complete safety suite of services, including adverse event case processing, signal management, and regulatory submission support ensuring your products remain safe and compliant.

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<h3>Key features of our pharmacovigilance services</h3>
Contact center

We provide comprehensive medical information services and adverse event intake through our global contact centers, ensuring seamless support for pharmaceutical companies worldwide. Our experts use the latest technologies to deliver 24/7 coverage in over 40 languages. We prioritize patient safety through meticulous data collection from multiple data sources, timely reporting and comprehensive adverse event management. Navigate regulatory requirements with confidence while enhancing patient care and trust in your brand.

Literature surveillance

Our PV literature surveillance services leverage cutting edge data mining technology and expert analysis to continuously monitor global scientific publications, ensuring early detection of potential safety signals.

Case processing

Cognizant is a leader in E2E case processing services, handling both clinical and post-marketing cases including case triage and data entry to submission process steps. Using advanced technology and experienced safety professionals, we ensure timely accurate reporting, utilizing robust safety databases like Argus, LSMV, ArigG, etc. With the capacity to process >4.2M case versions annually, we ensure speed, accuracy and scale. Our state-of-the-art automation tools streamline workflows, reducing human errors and enhancing data quality.

Aggregate reporting

Our aggregate report writing services ensure the preparation and submission of critical safety documents like PSURS, PBRERs and DSURs, supporting regulatory compliance across the globe. We leverage automation to compile and analyze safety data from multiple sources, providing comprehensive insights that drive informed risk-benefit decisions. We understand compliance with agencies like FDA, EMA, HPRA and PMDA and deliver high-quality reports to global submission standards.

Safety signal management

Our comprehensive safety insights help you make informed decisions about risk management and product safety. We track safety signals across therapeutic areas and geographies focused on risk-based timely detection, validation and prioritization of safety signals. The technology-enhanced approach to signal management analyzes data through multiple data sources, scientific literatures, ICSRs and other surveillance systems. This detailed analysis identifies emerging patterns and potential signals which can be assessed by our safety professionals, enabling precise detection.

Pharmacovigilance implementation, upgrade and management

Cognizant has helped more than 50% of the top 10 global pharma companies transform their PV environments to new platforms that utilize the latest technologies and processes. We provide full lifecycle support, including consulting, implementation and management. We partner with the leading platform providers to ensure we deliver the services you require with the latest innovations.

Pharmacovigilance and data migration

Cognizant has the experience in most PV platforms and data systems to help you transform your existing environment to new platforms. We utilize specialized migration tools and work with partners that enable migration time reduction by 40–50%.

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<h3>Pharmacovigilance in action</h3> <p>These are a sample of the solutions we deliver for industry leaders.</p>
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US-BASED PHARMA COMPANY

End-to-end case processing

US-BASED PHARMA COMPANY

End-to-end case processing

We provided full-service case processing, contact center services, aggregate report writing, safety surveillance and literature management and reconciliations covering 8,000+ cases, 4,500+ articles and 12+ aggregate reports.

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AN AMERICAN BIO PHARMACEUTICAL COMPANY

Maintaining 100% compliance

AN AMERICAN BIO PHARMACEUTICAL COMPANY

Maintaining 100% compliance

We delivered one of the first Veeva Vault safety solutions as part of providing end-to-end case processing, medical information management, inbound voice adverse event and quality mediation.

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FRENCH MID-SIZED PHARMACEUTICAL COMPANY

Creating SOPs and WIs for new platforms

FRENCH MID-SIZED PHARMACEUTICAL COMPANY

Creating SOPs and WIs for new platforms

We provided end-to-end case processing, including medical review affiliate support for post marketing and clinical trial cases, literature review and eTMP uploads for 7,000+ cases.

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TIER 1 PHARMA

Argus upgrade and migration of 2M+ cases

TIER 1 PHARMA

Argus upgrade and migration of 2M+ cases

We upgraded client platforms to Argus 8.2.3.1, including implementation, migration of cases, testing, performance, compliance, gateway configuration and environment setup to support M&A and regulatory compliance.

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EUROPEAN GLOBAL PHARMA COMPANIES

Managing volumes of over 25,000 cases

EUROPEAN GLOBAL PHARMA COMPANIES

Managing volumes of over 25,000 cases

We provided end-to-end case processing, literature review, medical translation, foreign case management, clinical trial support and post-market support for several leading European global pharma companies managing volumes of over 25,000 cases.

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JAPANESE LARGE PHARMA COMPANIES

Leading pharmacovigilance case processing in Japan

JAPANESE LARGE PHARMA COMPANIES

Leading pharmacovigilance case processing in Japan

We supported many large Japanese large pharma companies by providing case processing, clinical trial support, post-market support, medical translations and literature support, including search and screening for thousands of cases across many safety database platforms and delivering 100% compliance with quality TAT and SLAs.

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<h3>Thought leadership</h3>
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Using AI for signal management could transform pharmacovigilance

Signal management is a critical aspect in pharmacovigilance, which ensures effective monitoring of pharmaceutical products in terms of their safety and efficacy. The integration of AI in PV offers advanced methodologies—to enhance signal management and the safety of patients.

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Blue molecular cells
Pharmacovigilance considerations for biologics and biosimilars

This article explores the various aspects of safety monitoring and risk management for biologics and biosimilar pharmaceutical products. Given the complexity of these products, robust pharmacovigilance strategies are crucial for ensuring patient safety.

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SHOWCASE
<h3 style="text-align: left;">Featured work</h3>

LIFE SCIENCES

Total quality management for patient care

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Everest Group
Cognizant recognized as a Leader in Everest Group Life Sciences Operations PEAK Matrix® Assessment 2023

Cognizant’s double-digit client and revenue growth, broad set of technology solutions and deep domain/process expertise gave our team the edge over the competition.

Read the case study

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LIFE SCIENCES MANAGEMENT
<h3>Leadership</h3>
Gaurav Marya

Strategic Business Unit Head and Business Unit Integration Lead, Life Sciences

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Serving customers by looking forward as well as back is a big promise, but the power of today’s new digital capabilities is vast and growing.

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