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Pharmacovigilance

 Ensuring Safety at Every Stage


At Kernel CRO,

Pharmacovigilance (PV) is more than a regulatory obligation, it’s a multidisciplinary commitment to safeguarding patient well-being across the product lifecycle. Our safety scientists, medical doctors, data analysts, and regulatory experts unite their diverse expertise to detect potential signals early, mitigate risks, and maintain strict global compliance.


​Core Pharmacovigilance Guidelines & Frameworks

ICH E2B Compliance

We follow ICH E2B guidelines for the electronic transfer and management of Individual Case Safety Reports (ICSRs), ensuring standardized data formats and seamless global submissions.


 EU-GVP & Regional Regulations

Our team stays current with evolving guidelines, such as Good Pharmacovigilance Practices (GVP) in the EU and local requirements in the MENA region, ensuring continuous alignment with best practices.

Risk Management & Periodic Reporting

We develop Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other documentation per ICH guidance to maintain transparency with health authorities and stakeholders.


​Multidisciplinary Team Approach 

     Safety Scientists & Medical Doctors

Identify, analyze, and interpret adverse events to evaluate causal relationships and clinical significance.

Data Analysts & Epidemiologists

Harness advanced analytics, detect safety signals, and conduct pharmacoepidemiologic studies to validate findings in large datasets.

Regulatory Affairs Specialists

Navigate regional and international regulations (ICH, EU, local laws), ensuring prompt, accurate safety reporting and clear communication with health authorities.

 Medical Writers & Project Managers

Compile precise, compliant documentation—including ICSRs, PSURs, and RMPs—and coordinate timelines, deliverables, and sponsor communications.

Throughout reporting data  and international spanning safety scientists, clinicians, and specialized writers continues broader adapt surveillance enabling

Key Pharmacovigilance Service

PV System Setup & Consultancy

  • Develop SOPs, training programs, and infrastructure compliant with global standards.
  • Coordinate with cross-functional teams to embed PV seamlessly into clinical operations.

Adverse Event Reporting & Management

  • Collect, assess, and submit AE/SAE reports in accordance with ICH E2B guidelines.
  • Integrate MedDRA and WHO-Drug coding for consistent event classification.

Signal Detection & Risk Mitigation

  • Apply advanced statistical tools to unearth emerging safety concerns early.
  • Propose and implement targeted interventions and RMPs to safeguard patient welfare.

PV Audits & Compliance Monitoring​

  • Conduct in-depth assessments to validate adherence to local and international regulations.
  • Recommend corrective actions for continuous quality improvement.

Flexible Service Options to Meet Your Needs

At Kernel, we understand that every project is unique. That’s why we offer a range of service options to fit your specific requirements:

Full-Service Support

 End-to-end pharmacovigilance and post-marketing surveillance for specific study or product.


Standalone Services

Manage any part of your pharmacovigilance project, from signal detection to regulatory reporting.

 
Full Outsourcing

Comprehensive management of your pharmacovigilance function across multiple studies or products.


Whether you need support for a single project or a long-term partnership, 

we provide scalable solutions to meet your needs.

Contact us