North America
SAFETY YOU CAN TRUST. COMPLIANCE YOU CAN DEFEND.
Pharmacovigilance for
the Modern World
Patient safety and regulatory compliance are inseparable. HiRO’s Pharmacovigilance team delivers end-to-end safety oversight across the product lifecycle—combining expert medical review, disciplined processes, and global regulatory awareness to protect patients and support confident regulatory decision-making.
From early development through post-marketing, our PV services are built to scale with your program, providing proactive risk management, reliable reporting, and systems designed to meet evolving global requirements.
What Makes Our Approach Different?
We approach pharmacovigilance as a strategic function, not a reactive task. By combining tailored safety strategies, technology-enabled workflows, and continuous regulatory monitoring, we reduce risk, improve efficiency, and give sponsors confidence that safety obligations are always met.
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
* Proactive * Compliant * Scalable * Reliable
SAFETY YOU CAN DEPEND ON
Pharmacovigilance Backed
By Global Expertise
Effective pharmacovigilance requires more than reporting. It demands consistency, accountability, and regulatory foresight. Our teams ensure safety data is accurate, traceable, and compliant with global requirements, supporting timely submissions and inspection-ready documentation at every stage.
Linked People. Linked Processes. Linked Outcomes.
Pharmacovigilance specialists collaborate seamlessly with Medical Monitoring, Clinical Operations, Data Science, Regulatory Affairs, and Quality teams—ensuring safety insights are shared early and applied consistently across regions.
Safety Insight That Informs Action
We transform complex safety data into clear, actionable understanding. Through structured review, benefit-risk assessment, and sponsor-ready outputs, we help teams see emerging trends, understand their implications, and respond with confidence.
SAFETY AWAITS
The Pharmacovigilance
Sponsors Depend On
01
PV Quality Management
Customized Safety Management Plans, targeted training, and continuous regulatory monitoring to support compliant, scalable safety operations.
02
Safety Report Management
End-to-end handling of ICSRs, literature cases, and health authority reports, ensuring accurate processing, medical review, and timely submission.
03
Benefit-Risk Management
Strategic support across pre- and post-marketing phases, including RMPs, DSURs, PSURs and PBRERs, and ongoing signal detection.
04
PV Database Management
Expert use of industry-standard systems to support data quality, workflow management, and global reporting requirements.
05
Global Regulatory Compliance
Aligned submissions and reporting across FDA, EMA, PMDA, NMPA, and other health authorities, supporting inspection readiness worldwide.
Gain More Than Compliance.
Gain Confidence.