Pharmacovigilance
Protect patients.
Preserve trust.
Ensure compliance.
Pharmacovigilance helps companies monitor drug safety, manage adverse events, and comply with global regulations.
Ensuring safety and compliance at every step.
In today’s regulatory environment, robust pharmacovigilance isn’t optional – it’s essential. athagoras helps Life Sciences companies monitor product safety, manage risk, and meet evolving compliance standards with confidence.
We provide end-to-end PV support, including system implementation, safety screening, reporting, and QPPV services.
Our proactive approach ensures early detection of safety signals, reduces compliance risks, and safeguards both patient well-being and brand reputation.
With athagoras as your partner, you can strengthen your pharmacovigilance systems, maintain regulatory trust, and secure the long-term success of your products.
Our solutions
Safeguarding patients.
Supporting innovation.
PV systems
Build a strong foundation for safety and compliance.
A well-structured Pharmacovigilance System is essential for protecting patients and meeting global regulatory expectations. athagoras helps you establish every critical component – from your Pharmacovigilance System Master File (PSMF) and SOPs to Safety Data Exchange Agreements (SDEAs) with partners.
We also support ongoing quality assurance, internal audits, and team training to ensure your system remains compliant, audit-ready, and resilient over time.
- PSMF
- SOPs
- Contracts
- Quality assurance
- Training
- Audit
PV Screening
Stay ahead of risk. Protect patients.
Effective PV screening is essential to safeguarding patient safety and ensuring compliance. athagoras implements robust, proactive screening practices – including case reviews, signal detection, and literature monitoring – to identify potential safety issues early.
Our approach enables timely risk mitigation, reduces regulatory exposure, and supports continuous patient protection throughout the product lifecycle.
- Case reports
- Signal detection
- Literature search
- Monitoring ADRs
- Legislation screening
PV reporting
Translate data into action. Enhance safety.
Timely, accurate reporting is a cornerstone of effective pharmacovigilance. athagoras supports the preparation and submission of essential safety documents – such as Risk Management Plans (RMPs) and aggregate reports – delivering a clear, ongoing view of your product’s safety profile.
These insights empower you to proactively implement safety measures, manage risks, and maintain full regulatory compliance throughout the lifecycle.
PV roles
Trusted experts in critical safety positions.
Regulatory compliance starts with the right people in the right roles. athagoras provides experienced professionals for essential pharmacovigilance positions – including Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officer (LSO).
With our experts overseeing your drug safety activities, you ensure compliant monitoring, timely reporting, and continuous patient protection across all markets.
Safety Studies, PASS, PAES
Generate trust. Strengthen safety. Support long-term success.
Robust post-market evidence is key to maintaining regulatory confidence and market credibility. athagoras designs and executes high-quality Post-Authorization Safety Studies (PASS) and Efficacy Studies (PAES) that meet regulatory standards and inform benefit-risk evaluations.
As an EMA ENCePP partner, we deliver scientifically rigorous, GVP-compliant studies – whether imposed or voluntary – managing every step from protocol development to multicenter execution and publication. With our support, you ensure timely delivery, full compliance, and meaningful real-world insights.
- EMA ENCePP partner
- Imposed and non-imposed PASS
- Data access
- Study protocol development
- Statistical analysis
- Reporting & publication
- Multi-center coordination
Get in touch
Let’s move life sciences forward – together.
End-to-end support,
wherever your project starts.