Pharmacovigilance is an area showing an increased relevance in the last years with a
meaningful impact in the value chain associated to the marketing of medicines.
Considering the requirements for the application of the legislative environment which approves the Regulation of the Pharmacovigilance System for Human Use Medicines, and according to Directive 2010/84/EU amending Directive 2001/83/EC; Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 and in the Commission Implementing Regulation (EU) No 520/2012, the need for a complete Pharmacovigilance system has emerged.
Under this scope, PharSolution has created a complete and tailored range of compliant and
cost-effective pharmacovigilance services, perfectly adjusted to the current and new requirements. This
integrated and full-service solution enables a Marketing Authorization Holder to fulfil its legal tasks
and responsibilities in relation to pharmacovigilance, monitor the safety of authorised medicinal products
and detect any change to their risk-benefit balance, whilst ensuring patient safety.
We offer solid know-how and experience of pharmacovigilance for global and small pharma, adjusting our services to client´s needs, providing either a complete and stand-alone solution, or a reinforcement to the client´s existing pharmacovigilance system.
The Pharmacovigilance department at PharSolution has high-level expertise in pharmacovigilance (with a team of dedicated, skilled, and experienced pharmacists and life science professionals, with continuous support of medically qualified person) and hosts a fully E2B compliant and validated safety management database, namely iPHASy.
We can provide the following end-to-end pharmacovigilance services:
Qualified Person and Local Contact Person for Pharmacovigilance
• EU-Qualified Person for Pharmacovigilance (EU-QPPV) and Deputy QPPV provision;
• Provision of the Local Contact Person for Pharmacovigilance at national level;
• Single point of contact on a 24-hour basis.
Pharmacovigilance System Master File (PSMF)
• Set up and implementation of a Pharmacovigilance System, including the preparation of a new PSMF;
• Revision and improvement of an existing pharmacovigilance system;
• Continuous maintenance of the PSMF.
Literature surveillance and review
• Worldwide weekly literature search;
• Local weekly literature search;
• Assessment of the literature results;
• Periodic screening of Medical Literature Monitoring (MLM) results obtained by EMA.
Handling of Adverse Events (AE) and Adverse Drug Reactions (ADR)
• Collection, assessment and expedited reporting of AE/ADR;
• MedDRA coding and case narrative preparation;
• Processing of initial/follow-up Individual Case Safety Reports (ICSRs);
• Handling of ICSRs resulting from the MLM service of EMA;
• AE/ADR reconciliation with clients and clients´ partners.
Aggregate Safety Reports
• Schedule, preparation and submission of Periodic Safety Update Reports (PSURs);
• Elaboration of Addenda to the Clinical Overview (ADCO) and other aggregate safety reports;
• Assistance with responses to regulatory enquiries.
Risk Management Plan (EU-RMP)
• Pre-submission development for new applications;
• Elaboration and maintenance of EU-RMP.
Signal Management and ongoing safety evaluation
• Overseeing safety profiles of client´s medicinal products and any emerging safety concerns;
• Medical evaluation of pharmacovigilance data and safety signal detection, review and evaluation;
• Benefit-Risk balance assessment.
Pharmacovigilance audits and inspections
• Audit of pharmacovigilance systems;
• Competent Authority inspection preparation and assistance;
• Development of Corrective Action and Preventive Actions (CAPA) plan dealing with inspection or audit findings.
• Up-to-date and comprehensive/tailored-made pharmacovigilance training;
• Basic pharmacovigilance training of medical / sales representatives and others.
Quality Management System
• Quality Management System oversight;
• Development and regular update of Standard Operating Procedures (SOPs);
• Deviations and non-conformity management;
• Periodic compliance and status reporting;
• Safety Data Exchange Agreements (SDEA) set up and maintenance.
• Eudravigilance registration;
• Insertion and maintenance of products´ information in the Extended Eudravigilance
Medicinal Product Dictionary
(xEVMPD) using the XEVPRM format;
• Expedited electronic reporting to Eudravigilance.
Communication with regulatory authorities
• Assistance with responses to Competent Authorities safety enquiries;
• Communication with regulatory agencies regarding emerging safety issues.
Full and Complete Pharmacovigilance Service
A comprehensive and integrated pharmacovigilance solution comprising all the aforementioned services.