- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
Making the creation and management of your PV System easy, compliant, and safety focused.
A pharmacovigilance system is a structured and comprehensive framework designed to ensure the ongoing monitoring, evaluation, and management of the safety of pharmaceutical products throughout their entire life cycle.
This system encompasses various processes, including the collection, analysis, and reporting of adverse event data to detect potential risks. It also ensures legal compliance with the pharmacovigilance protocols and Good Vigilance Practices (GVP) guidelines of regulatory bodies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Every pharmacovigilance system requires expert management to create and maintain it, aligned with those mandatory regulatory processes and guidelines, to protect the health and well-being of patients, and ensure that Marketing Authorisation Holders (MAHs) and the products they are authorized and responsible for, remain compliant.
Qualified Persons for Pharmacovigilance (QPPVs), their deputies, the network of associated Local Persons for Pharmacovigilance (LPPVs), and all QPPV office support personnel manage the pharmacovigilance system, but at different times there is also a need for other medical or technical specialists to support the system.
Safety Physicians, who are highly skilled medical professionals, specialise in monitoring, assessing, and managing adverse reactions and the potential risks associated with medicinal products.
Their expertise helps maintain the highest standards of drug safety, contributing to better patient outcomes and overall public health.
Medical Writers provide specialised technical support with the construction and content of Aggregate Reports, Risk Management Plans and other safety reports.
Individual Case Study Report (ICSR) management: medical assessment and documentation of case reports in clinical trials (SAEs, SUSARs) and post-marketing.
Safety Data Management (Article 57/xEVMPD services and MedDRA coding).
Benefit-Risk Assessment.
Risk Management Plan (RMP), Risk Evaluation and Mitigation Strategy (REMS).
Risk Minimization Measures (Routine and Additional RMMs).
Medical Writing for Aggregate Safety Reports including:
Development Safety Update Reports (DSURs),
Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs),
Periodic Adverse Drug Experience Reports (PADER),
Addendum to the Clinical Overviews (ACOs).
Meeting commitments and responding to requests from competent authorities.
Communication about safety concerns or changes to the risk-benefit balance of products to competent authorities, healthcare professionals and patients.
Interaction between pharmacovigilance and quality defect systems.
Keeping product information up-to-date and implementing of safety variations.
Maintaining business continuity in the term of staff, processes and technology used.
iVigee’s pharmacovigilance team brings together a range of experts, many with more than 20 years of experience in the industry, who are dedicated to ensuring the highest standards of patient safety and regulatory compliance. These also include Safety Physicians and Medical Writers, whom we can also provide on an interim support basis.
Central to our approach for creating high performance Pharmacovigilance Systems is iViReg, our GxP-validated regulatory intelligence tool.
The iViReg platform serves as a centralized knowledge hub, enriched by the expertise of over 120 local pharmacovigilance experts and offering comprehensive worldwide coverage of both global and local regulations across more than 90 countries.
iViReg streamlines the regulatory compliance process, ensuring a smoother experience for our clients, and gives an always current blueprint for what is required in which location or region.
Alongside traditional methods, we also employ our case intake platform iViMedic, jointly developed with Deloitte, to provide a fully automated, AI assisted, 24/7 conversation system that streamlines safety data acquisition and efficient response, with reduced time and cost.
That safety data sits within an Oracle Argus safety database system, and we are renowned Argus experts with decades of experience in the configuration, and implementation of Argus systems.
Additionally, we use our fully GxP validated iViSight advanced reporting platform to provide powerful insights and comprehensive signal management, for fast, data-informed decision making.
iVigee stands out as a provider and partner offering a real difference in our use of knowledge and technology.
We understand your unique needs and can deliver tailored solutions that align with your objectives through our combination of global reach, innovative technology, and history of success.
