Pharmacovigilance & Safety
Pharmacovigilance is increasingly becoming a very crucial step in the drug and device development cycle, mostly due to increased regulations by the EMA and FDA (as well as local authorities) who are aiming to improve patient safety in both clinical development and post-market.
We offer both:
Pharmacovigilance Technology Solutions
The right safety database offers solutions to multiple challenges that a pharmacovigilance team faces – from the increasing complexity of the regulatory landscape to the integration of RWE. We will support you on how to choose the right technology and how to experience a smooth implementation and transition project. Moreover, throughout the whole life cycle of your system, you will enjoy the managed services by the IT Services. We will continue to support you with everything about the technology and services you may need.
We provide Vendor Selection
We have a proven track record in defining user requirements and choosing a fit-for-purpose pharmacovigilance system, database and reporting system within a compliance strategy.
We provide System Implementation
- Support in the definition of Business processes and User Requirements
- Validation plan and report, Risk Assessment, traceability matrix
- Architectural Design Definition
- Deployment, configuration, and test
- Systems integration
- Data migration from legacy PV systems
- Training for users
We provide end-to-end IT Services
Off-the-shelf Pharmacovigilance Technology Solutions: Oracle Argus and Argus BluePrint
We have been Oracle Gold Partner since 2011. We act as trusted advisors and experts in building, selling and providing value-added services for Oracle Life Sciences technology.
Pharmacovigilance and Safety Services
seQure is the business unit of Arithmos, related to Quality Compliance and Consulting Services.
We provide Pharmacovigilance services to our customers to support their Pharmacovigilance processes and ensure business continuity.
Pharmacovigilance processes
With seQure Pharmacovigilance services, for our customers we provide a complete portfolio of drug safety and risk management services ranging from case processing and reporting of Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) to the collection, monitoring, assessment, and analysis of drug safety information and the detection of new safety concerns.
Using our network of resources, we can provide the following services:
- Case processing and management
- Electronic reporting
- Signal detection and management
- Medical monitoring
- Pharmacovigilance System Master File (PSMF) preparation and maintenance
- Periodic Reporting (PSURs, DSURs, Addendum to Clinical Overview)
- Literature Screening
- Risk Management Plans (RMR) preparation and update
- Set-up and maintenance of an EU compliant PV system
EU QPPV and Deputy
We support pharmaceutical companies and biotech’s with a full suite of services, including acting QPPV and deputy QPPV for pharmacovigilance in the EU:
- EU QPPV and/or Deputy services
- Availability 24hrs/7days and business continuity
Local Safety Officer/Local Contact Person for Pharmacovigilance
Our professionals are well qualified to cover the role of Local Safety Officer/ Local Contact Person for Pharmacovigilance and to liaise with local authorities on behalf of our customers. Over the past years, we have been engaging with numerous pharmaceutical companies to support them with Local Responsible Persons/ Local Contact Person for Pharmacovigilance in different countries, and, we have gained robust experience in providing such a role in Italy. We will be happy to support you with our in-house resources and partners network which have full competence in local regulations
