List of Pharmacovigilance outsourcing companies in India

Here is a list of large and best Pharmacovigilance (PV) outsourcing companies or drug safety service providers in India.

Tata Consultancy Services (TCS) – TCS offers end-to-end drug safety services, including case processing, signal detection, and regulatory compliance, leveraging AI and automation to enhance drug safety and compliance.
Cognizant Technology Solutions – Cognizant provides comprehensive PV solutions, from adverse event reporting to risk management, using advanced analytics and automation to streamline regulatory compliance and drug safety monitoring.
IQVIA – A global leader in life sciences, IQVIA delivers data-driven Pharmacovigilance solutions, integrating AI and real-world evidence to improve adverse event detection, risk assessment, and regulatory reporting.
Parexel – Parexel supports biopharmaceutical companies with full-spectrum PV services, including case processing, medical review, and regulatory submissions, ensuring drug safety and compliance across global markets.
ICON LLC – ICON provides Pharmacovigilance and risk management solutions with a focus on advanced analytics, case management, and regulatory support to enhance patient safety and regulatory adherence.
Accenture – Accenture offers innovative PV solutions powered by AI and automation, helping pharma companies streamline adverse event reporting, compliance, and risk mitigation in a cost-effective manner.
Wipro – Wipro delivers technology-driven PV services, including adverse event reporting, literature monitoring, and regulatory submissions, utilizing AI and automation to enhance efficiency and compliance.
Syneos Health – Syneos Health provides integrated Pharmacovigilance services, combining data analytics and regulatory expertise to ensure drug safety, risk management, and compliance for biopharmaceutical companies.
Tata Elxsi – Tata Elxsi offers digital PV solutions, including AI-based adverse event detection and automation-driven compliance support, helping pharma companies manage drug safety effectively.
Fortrea – Fortrea specializes in outsourced PV services, offering case processing, risk assessment, and regulatory support to optimize drug safety and compliance processes for pharma and biotech firms.
Infosys – Infosys leverages digital transformation and AI-driven automation to provide end-to-end PV solutions, including adverse event processing, signal detection, and regulatory compliance support. They are master in providing Pharmacovigilance consulting services
Labcorp – Labcorp provides Pharmacovigilance and safety solutions, supporting clinical trials and post-market surveillance with comprehensive case processing, regulatory reporting, and risk management services.
Deloitte – They have handled many projects as Pharmacovigilance consultants. Infosys and Deloitte are good for Pharmacovigilance consulting services.

Here is a list of small and midsized Pharmacovigilance outsourcing companies or service providers in India.

Pharmalex – Pharmalex offers comprehensive Pharmacovigilance (PV) services, including case processing, signal detection, risk management, and regulatory compliance, helping pharma companies navigate global safety requirements.
Product Life Group (PLG) – PLG provides end-to-end drug safety services, including adverse event reporting, medical writing, and safety risk management, ensuring compliance with evolving regulatory frameworks.
Navitas – Navitas specializes in technology-driven PV solutions, offering case processing, aggregate reporting, signal management, and compliance support to optimize drug safety and regulatory adherence.
Techsol Lifesciences – Techsol delivers AI-powered PV solutions, including cloud-based safety databases, case management, and signal detection, enhancing drug safety monitoring and regulatory reporting.
Norwich Clinical Services – Norwich Clinical Services provides global PV support, offering case processing, risk evaluation, and regulatory compliance solutions tailored to pharmaceutical and biotech companies.
Thermo Fisher (PPD) – Thermo Fisher (PPD) services provide end-to-end Pharmacovigilance support, including adverse event monitoring, risk management, and regulatory reporting, ensuring patient safety and compliance.
Indegene – Indegene offers AI-driven PV solutions, integrating automation, real-world data, and analytics to enhance adverse event detection, case processing, and regulatory compliance.
PrimeVigilance – A leader in global PV services, PrimeVigilance provides case management, risk evaluation, and regulatory support, ensuring drug safety compliance across multiple regulatory jurisdictions.
Clinevo – Clinevo specializes in PV technology solutions, offering cloud-based safety systems, automation-driven case processing, and compliance services for pharmaceutical and biotech firms.
Sitero – Sitero provides full-spectrum PV solutions, from adverse event reporting to risk management and regulatory compliance, leveraging technology to enhance drug safety monitoring.
Quinesca – Quinesca offers specialized PV services, focusing on case processing, signal detection, and regulatory submissions, ensuring efficient and compliant safety operations for pharmaceutical companies.
Quanticate – Quanticate provides data-driven PV and risk management solutions, offering case processing, medical review, and aggregate reporting to support global drug safety compliance.
Continum – Continum delivers drug safety outsourcing solutions, including case processing, signal management, and safety database support to ensure regulatory compliance and drug safety.
Clinexel – Clinexel provides tailored PV services, offering end-to-end case processing, risk management, and compliance support for pharmaceutical, biotech, and medical device companies.
Rhyme Lifesciences –They deal with outsourced Pharmacovigilance activities. They are Pharmacovigilance vendors from quite some time and have handled some Pharmacovigilance projects from few Pharma companies

If you are a Pharmaceutical company, the you can consider these outsourcing Pharmacovigilance companies based on the budget. Very new Pharmacovigilance service providers are always at risk of getting closed if they don’t get many clients. However established pharmacovigilance service providers always have a good chance to sustain.

Points to consider while outsourcing activities of Pharmacovigilance to service providers – This can be achieved by conducting Audits

1. Regulatory Compliance & Standards

Ensure the provider complies with global and local regulatory requirements (FDA, EMA, MHRA, ICH, WHO, etc.).
Check for adherence to Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP).
Ensure they are updated with evolving regulations and guidance.

2. Experience & Expertise

Evaluate the provider’s experience in pharmacovigilance, especially in your therapeutic area.
Assess their expertise in Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and signal detection.
Review their team’s qualifications (physicians, pharmacists, regulatory experts).
Look for the list of client’s they have. You can also take feedback from those clients.

3. Technology & Infrastructure

Verify their use of compliant PV databases (e.g., Argus, ArisG, Veeva Vault Safety).
Ensure compatibility with your systems for seamless integration.
Check for automation capabilities in adverse event processing and reporting.

4. Data Security & Confidentiality

Assess data protection measures, compliance with GDPR/HIPAA, and cybersecurity protocols.
Ensure secure transmission and storage of patient data.
Check their business continuity and disaster recovery plans.

5. Quality Assurance & Audits

Ensure a strong quality management system (QMS) is in place.
Check past audit reports and regulatory inspections.
Evaluate their ability to handle deviations, CAPAs (Corrective and Preventive Actions), and risk mitigation.

6. Scalability & Flexibility

Assess their ability to scale operations based on your needs.
Verify flexibility to handle increased case volumes or new regulatory requirements.

7. Communication & Collaboration

Ensure clear communication channels and well-defined escalation pathways.
Review reporting structures and governance models.
Establish key performance indicators (KPIs) and service-level agreements (SLAs).

8. Cost & Value Considerations

Conduct a cost-benefit analysis beyond just pricing.
Check for hidden costs related to system integration, training, or additional services.
Ensure contract transparency with defined payment terms.

9. Business Continuity & Risk Management

Evaluate the provider’s contingency planning for operational disruptions.
Ensure they have backup systems for PV operations and compliance continuity.

10. Global Reach & Local Presence

Check if they have a global presence to support multi-region compliance.
Ensure they have local knowledge for region-specific reporting obligations.

If you are looking for a service provider your may contact us for more details t Pharmacovigilancejob@gmail.com.