Pharmaco Vigilance Services

Pharmaco vigilance services

Global and local pharmaceutical industries is focusing, a shift towards improved patient safety through proactive identification of risks and increased focus on safety regulations. They are increasingly looking to align global safety and regulatory strategies by integrating their regulatory and pharmacovigilance deliverables and moving towards a more proactive approach in risk identification and minimization. Additionally, monitoring social media for adverse drug reactions (ADRs) has gained a great deal of regulatory attention. This necessitates a broader framework for data gathering, comparison, and management. Companies will also have to leverage standard operating processes at the global and country level as well as across local networks, and establish accountability systems to ensure quality reports.

As your partner in ensuring patient safety, ClinSync offers end-to-end Pharmacovigilance Services for comprehensive coverage of safety operation needs. It creates a centralized pool of pharmacovigilance inputs to improve patient safety and regulatory compliance, achieve operational savings, and minimize litigation costs.



End to End case processing
Aggregate report writing such as PSURs, PBRERs, PADERs
Risk Management Plans & PBRER Line Listings
Risk Evaluation and Mitigation Strategies,
Literature screening and review
Signal detection and management
Company core data sheet update
SmPC update for generic molecules
Health authority responses as required
Audit and Inspection support
Developing SOPs based on good pharmacovigilance practices
Setting up of comprehensive pharmacovigilance system
Medical Impact Analysis
Tailored corporate training on pharmacovigilance
EU and local QPPV services