Pharmacovigilance
Strategic Services to Advance Your Goals
Pharmacovigilance plays a critical role in protecting patient safety by detecting, assessing, and preventing adverse effects throughout a product’s lifecycle. Our Pharmacovigilance services help companies establish and maintain compliant safety processes, ensuring timely reporting, risk management, and regulatory adherence. Whether supporting clinical development or post-marketing surveillance, we provide tailored solutions to meet evolving safety requirements while optimizing efficiency.
Pharmacovigilance Services
Aggregate safety report preparation
Signal detection and risk management
Pharmacovigilance system master file (PSMF) maintenance
Safety data exchange agreements
Qualified person for pharmacovigilance (QPPV) services
Adverse event reporting and follow-up
Literature surveillance
Individual case safety report (iCSR) management
Pharmacovigilance auditing and inspections
Safety database management
Regulatory intelligence and compliance
Technology Solutions
We are thought leaders on the use of automation/logic-based programming and AI for patient data and patient-facing documents. Innovations include:
AgileWriter.ai™
First-in-class AI tool for composing and managing clinical trial documents
Synterex also is a Microsoft Cloud AI Partner, which positions us to work closely with product management at one of the largest tech companies in the world to advocate for clients and deliver best-in-class user experiences.
Learn more about how we're leveraging technology for the good of the patient.