PharSafer
PharSafer is a global CRO specializing in Pharmacovigilance, Medical Affairs, and Regulatory Services, committed to protecting patients and ensuring compliance through innovative solutions and expert support. Founded in 2003, it offers comprehensive services including pharmacovigilance, regulatory strategy, training, auditing, informatics, and regulatory intelligence, with a mission to be recognized as a top-quality CRO in the world within five years. The company actively participates in industry events, provides regulatory intelligence updates, and offers a wide range of services to support compliance and safety in the pharmaceutical industry.
Industries
Nr. of Employees
medium (51-250)
PharSafer
Wisley, Surrey, United Kingdom, Europe
Products
Safety case automation platform
Platform for automated capture, triage and processing of safety reports to reduce manual workload and improve processing timeliness and consistency across product types.
Safety case automation platform
Platform for automated capture, triage and processing of safety reports to reduce manual workload and improve processing timeliness and consistency across product types.
Services
ICSR processing, triage, medical review, literature monitoring, signal detection, global safety report processing and expedited reporting.
Safety database selection, client installation, rental/access, implementation, validation, data migration and ongoing maintenance including MedDRA updates and portal integrations.
Consulting and operational support for regulatory submissions, QPPV/national QP provision, PSMF preparation, licensing strategy and global reporting alignment.
GCP and GVP audits, gap analyses, mock inspections, IT validation reviews and remediation planning to prepare for regulatory inspections.
PV and clinical safety training courses and bespoke programs covering SOPs, case processing, inspection preparedness and system use, delivered on-site or remotely.
Medical information enquiries handling, review and sign-off of educational/promotional materials, and medically-led case assessment and communications.
ICSR processing, triage, medical review, literature monitoring, signal detection, global safety report processing and expedited reporting.
Safety database selection, client installation, rental/access, implementation, validation, data migration and ongoing maintenance including MedDRA updates and portal integrations.
Consulting and operational support for regulatory submissions, QPPV/national QP provision, PSMF preparation, licensing strategy and global reporting alignment.
GCP and GVP audits, gap analyses, mock inspections, IT validation reviews and remediation planning to prepare for regulatory inspections.
PV and clinical safety training courses and bespoke programs covering SOPs, case processing, inspection preparedness and system use, delivered on-site or remotely.
Medical information enquiries handling, review and sign-off of educational/promotional materials, and medically-led case assessment and communications.
Expertise Areas
- Clinical and post-marketing pharmacovigilance
- Safety database selection, migration and validation
- Automation and AI governance in pharmacovigilance
- Medical literature monitoring and signal detection
Key Technologies
- Automated case capture and processing systems
- Safety database platforms and ETL migration tools
- Electronic submission gateway workflows (ICSR reporting)
- Medical literature monitoring and RIS/Excel export formats
News & Updates
Participation in World Drug Safety Congress Europe and Americas, Advanced Therapies Congress US, and other key events in October and November 2025.
EMA announced improvements to its MLM service effective April 2024, including daily searches and export options, with PharSafer reviewing and supporting clients.
CIOMS released a draft report on AI in PV, open for public comment until June 6, 2025, with PharSafer providing guidance and support.
A blog post discussing challenges and considerations in implementing automation in pharmaceutical safety processes.
An article exploring common surprises and challenges faced in managing safety information.
Guidance on safety database migration, including key considerations and best practices.
Participation in World Drug Safety Congress Europe and Americas, Advanced Therapies Congress US, and other key events in October and November 2025.
EMA announced improvements to its MLM service effective April 2024, including daily searches and export options, with PharSafer reviewing and supporting clients.
CIOMS released a draft report on AI in PV, open for public comment until June 6, 2025, with PharSafer providing guidance and support.
A blog post discussing challenges and considerations in implementing automation in pharmaceutical safety processes.
An article exploring common surprises and challenges faced in managing safety information.
Guidance on safety database migration, including key considerations and best practices.