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Pharmacovigilance Solutions
pharmacovigilance solutions
Pharmacovigilance Excellence Delivered
Pharmacovigilance (PV) is a complex and highly regulated field, with strict requirements varying across regions such as the EU, US, and other national jurisdictions. Navigating these regulations demands specialized expertise and a deep understanding of the legal frameworks in each market.
At Nearshore Macedonia, we ensure that every aspect of our services is managed by experienced PV experts, committed to maintaining the highest standards of quality and compliance.
Recognizing the legal obligations and associated costs of pharmacovigilance, our solutions are designed to be both cost-effective and fully compliant.
By integrating advanced automation with specialized expertise, we ensure that your pharmacovigilance operations are efficient, and aligned with global regulatory requirements.
key features & capabilities
Automated PV features for compliance
01.
Automated Case Intake & Processing
Email parsing, E2B mapping, duplicate checks, and workload distribution reduce manual effort by automating ~85–90% of cases.
02.
Real-Time Signal Detection & Analytics
AI and ML scan varied data sources to detect safety patterns early.
03.
Integrated Data Ecosystem
Connects with EHRs, clinical systems, and global safety databases like VigiBase or EudraVigilance.
04.
Scalable Cloud Platforms
Grow with your data; maintain speed and compliance as operations expand.
Business benefits
Efficiency, compliance, and cost savings
Accelerated Safety Signal Detection
Automated analytics and real-time monitoring reduce time to detect risks, improving patient safety intervention speed.
Efficiency & Compliance at Scale
Automation cuts case processing time significantly (e.g. by ~50%), reduces manual errors, and ensures consistent regulatory adherence..
Global Collaboration & Transparency
Integrated systems and data sharing support global stakeholder collaboration and reinforce trust through transparent safety oversight.
Cost Reduction & Operational Optimization
AI and automation reduce manual workload, cut operational costs (~30% in some cases), and streamline drug safety workflows.
+
Countries Worldwide
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15+
k
Happy Customers
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2.5k
LATEST CASE STUDIES
Introduce Our Projects
Explore our diverse portfolio of innovative projects, showcasing our commitment to delivering tailored, high-impact solutions.
