SAFETY AND PHARMACOVIGILANCE

Trusted language solutions for the speed of science

IQVIA Language Solutions helps you to accelerate the global flow of healthcare intelligence across patients, providers, regulators, researchers and markets.
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Solutions IQVIA Technologies Language Solutions Safety and Pharmacovigilance

Safety and Pharmacovigilance Translation Services

At IQVIA Language Solutions, we are different from a traditional language vendor: our safety and pharmacovigilance translation capabilities operate within an organization that delivers end-to-end pharmacovigilance and safety services. Rather than adding safety expertise to a translation workflow, our team brings language capability directly into the safety ecosystem.

This integrated model connects language specialists, safety professionals, technology and established workflows within the same organization. The result is a more streamlined approach to managing multilingual safety information across markets, with greater speed, scalability and operational efficiency.

Service Highlights

SAFETY AND PHARMACOVIGILANCE

Scale

Handle high-volume safety translation requirements across all markets and languages, with capacity designed to scale with surges and operational shifts.

Speed

Accelerate translation and processing via workflows that are embedded within IQVIA’s safety technology and operations, to support demanding reporting timelines.

Cost

Replace the friction and overhead associated with managing multiple vendors with an integrated model supported by purpose-built technology and automated workflows.
SAFETY AND PHARMACOVIGILANCE
When language fails, safety signals fail
Successful pharmacovigilance activities depend on safety information being understood accurately and acted on quickly. For global products, that safety information arrives across multiple countries, systems and languages, against fixed reporting timelines. If translation is delayed or incomplete, important details can be harder to identify, assess and communicate in time.
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The data problem

Safety information can arrive as scanned documents, handwritten reports, non-editable files and other variable formats. Within this volume of information, important details about an adverse event can be difficult to identify and interpret without the right language and subject matter expertise. Errors, omissions or inconsistencies in translation can affect how safety information is understood and assessed, potentially obscuring details that contribute to the identification of a safety signal.
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The clock problem

Safety reporting operates against fixed timelines, so translation delays can become pharmacovigilance delays. Every additional handoff or rework cycle reduces the time available to review information, identify potential signals and meet reporting requirements.
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The consequence

When safety information is not translated accurately or delivered on time, potential safety signals may take longer to identify or communicate. This can contribute to missed regulatory reporting deadlines, compliance issues, legal exposure and reputational damage and, most importantly, can delay action on information relevant to patient safety.

IQVIA Language Solutions helps reduce these risks by embedding language expertise within established safety operations, combining pharmacovigilance expertise, technology and human review to support accurate and timely communication of safety information.

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Safety and Pharmacovigilance Content We Translate

Case Processing & Safety Reporting

Case Processing and Safety Reporting

We translate and support the processing of safety information required for case management, reporting and regulatory communication, including: 

  • Individual Case Safety Reports (ICSRs)
  • Adverse event reports (AERs)
  • Serious adverse event (S/AE) case narratives
  • Patient narratives
  • Periodic Safety Update Reports (PSURs) and periodic benefit-risk evaluation reports
  • Risk Management Plans (RMPs)
  • Aggregate reporting content
  • Regulatory forms and authority correspondence 
  • Follow-up queries and source document requests

Post-Authorization & Product Lifecycle

Post-Authorization and Product Lifecycle

Language support continues beyond individual case processing, covering content associated with ongoing product safety, medical information and post-authorization requirements:

  • Safety variation wording and labeling change notifications
  • Direct Healthcare Professional Communications
  • Batch record translation, including handwritten and non-editable formats
  • Supply chain and distribution documentation, including Good Distribution Practice guidance
  • Medical information content and inquiry responses
  • Abstracts, articles and literature review content
  • Social media and digital channel monitoring 
  • Same-day interpreting for Medical Information teams

Medical Device Post-Market Surveillance

Medical Device Post-Market Surveillance

For medical device manufacturers, we support multilingual post-market surveillance and vigilance activities, including:

  • Post-market surveillance (PMS) reports
  • Vigilance reports and adverse event reports
  • Complaint handling reports
  • Post-market clinical follow-up (PMCF) documentation
  • Device labeling and instructions for use (IFU) updates prompted by new safety information or regulatory change

PMCF documentation is continually updated and requires version control across languages. Where labeling changes affect only specific content, translation can be focused on the revised sections rather than repeating unchanged material. This helps maintain consistency across language versions while supporting efficient management of ongoing safety and regulatory updates.

Beyond Translation: Support Across the Safety and Pharmacovigilance Process

Because we provide end-to-end safety and pharmacovigilance services, language support is embedded within the broader safety operation rather than managed separately by a third-party language vendor. This creates a more connected approach to managing multilingual safety information across products, markets and the wider safety process.

Integrated, Not Appended

When safety operations expand into new geographies, language support is already on-board. There is no separate language vendor to assess or translation infrastructure to implement, helping new markets become operational without introducing an additional layer of complexity or delay.

Connected Systems

Language workflows can connect with the systems and technology you are already using across your pharmacovigilance and safety operations. IQVIA's safety technology ecosystem supports the management of safety information through established platforms and integrations.

Shared Expertise

Linguists and project managers work alongside IQVIA's safety and clinical experts. Where appropriate, this allows knowledge to move directly between language and safety teams, rather than across separate organizations, supporting greater continuity throughout the process.

Data Security

Working with IQVIA Language Solutions eliminates the need to transfer sensitive safety data to third parties, supporting a more controlled approach to data management.

IQVIA's rigorous approach to data protection is best-in-class and designed to support global requirements, including GDPR and China's Personal Information Protection Law (PIPL).

Our Approach to Pharmacovigilance Translation

Not every piece of safety content requires the same level of translation. The right approach depends on how the information will be used and the risk attached to it.

AI-Delivered

Secure machine translation supports intake, triage and comprehension, where the requirement is to understand what has arrived and decide whether it needs further action. Suited to high-volume, lower-risk content where certified translation is not required.

Expert-Reviewed

AI-assisted translation combined with qualified linguist review and quality assurance. Certification is available on request, making this approach suitable for regulated, patient-facing and submission-bound content.

Human-Delivered

Where interpretation, scientific judgment or defensibility is critical, translation is led by experts with relevant subject matter expertise and scientific review.

Safety-Specific Controls

Across all approaches, safety-specific controls are applied at the points where safety content differs from other regulated material.
Incoming case information arrives as scanned documents, handwritten reports and non-editable files. OCR and AI-enabled processing extract and structure this content, with human verification applied to the output.

Variable Source formats

Translation memories, term bases and MedDRA-aligned terminology maintain consistency across cases, products and markets.

Controlled terminology

Quality assurance checks and an audit trail record how each translation was produced and reviewed. For regulated safety content, an accurate translation without that documentation may not be sufficient during an inspection.

Documented review

Workflows are built around 24 to 48-hour turnarounds, so preparation, review and delivery fit within reporting windows rather than competing with them.

Fixed reporting timelines

CAPABILITIES

Regulatory Frameworks and Authorities We Support

At IQVIA Language Solutions, we support the translation of safety and pharmacovigilance content used across global regulatory authorities, pharmacovigilance frameworks and established reporting standards.

These frameworks and systems define requirements for the collection, management and communication of safety information across markets. For example, EudraVigilance facilitates the electronic exchange of individual case safety reports and supports the detection and evaluation of potential safety signals in the European Economic Area.

For medical devices, our language support extends to content associated with the EU MDR and IVDR, including post-market surveillance and vigilance documentation.

Why IQVIA Language Solutions?

Delivery at Scale

We translate more than 1,000 safety cases per day, supporting high-volume pharmacovigilance programs across markets.

Local Expertise With AI-Assisted Workflows

In-country linguists combine local language and cultural knowledge with AI-assisted processes to maintain accuracy and nuance when timelines are tight.

Depth of Pharmacovigilance Experience

Support ranges from specialist requirements in niche markets to complex, multinational pharmacovigilance programs.

Flexible Surge Capacity

Resourcing can scale to accommodate sudden increases in volume without relying on a fixed staffing model.

Global Coverage

7 language hubs, 20 dedicated locations, plus IQVIA’s global office network and in-country linguists provide access to language expertise across every market.

Frequently Asked Questions

Clinical trials cannot capture every rare or long-term effect or reflect the full range of real-world use. Once a product is marketed across multiple countries, ongoing safety monitoring can generate new information that needs to be assessed and communicated in the relevant local languages.
Pharmacovigilance translation can cover individual case safety reports, adverse event narratives, periodic safety reports, risk management documentation, regulatory correspondence, medical information content and other safety and post-authorization materials. The specific requirements vary depending on the product, market and intended use.
Translations are completed by qualified life sciences linguists, with controlled terminology managed through translation memories and term bases. Quality assurance checks and an audit trail provide documented evidence of how the work was completed and reviewed. For regulated safety content, translation without the supporting documentation – even if accurate – may not be sufficient during an inspection.
Because safety translation often requires 24- to 48-hour turnarounds, IQVIA Language Solutions has created specialized workflows to consistently meet these timelines for our customers.
IQVIA Language Solutions implements AI where it adds value to our processes and solutions. For more on when and how we use AI, visit our Language Technology page.
OCR and AI-enabled processing help extract and format content from handwritten, scanned and other non-editable documents, with human verification applied where necessary to review the output.
Yes, we translate medical device post-market surveillance and vigilance materials, including post-market surveillance reports, vigilance and adverse event reports, complaint documentation, post-market clinical follow-up materials and labeling or instructions for use updates.
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