Pharmacovigilance Our services • Pharmacovigilance organisations and systems: Setting up pharmacovigilance system, Preparation of Pharmacovigilance System Master File (PSMF), Procedures and Safety Data Exchange Agreements (SDEA), QPPV services. • Pharmacovigilance / safety documents: Assessment a product’s risk benefit profile, Writing and maintenance of RMP in accordance with GVP Module V, Writing of DSURs, PBRERs… • Pharmacovigilance audits (PV audits) and inspection support: SOP reviewing/writing, Conducting audits of sites (internal/third party) and mock audits, Support on-site during the audit, Pre-audit training to staff. When work with us? The team The team covers the whole development process as a consultant or A team of highly qualified consultants with operational support, from concept to approval, on a global or multi- significant hands-on industry experience national projects. Do you have peaks of activities? Let us manage your safety reports. Our clients You wish to set up a PV service or outsource your PV activities PV? BlueReg has experts and tools to address your questions and needs. From start-ups to global pharma companies with punctual, repetitive or permanent need Among our latest missions for support. • Implementation of the PV system for a new pharma company, including drafting PSMF and procedures, staff trainings… Why work with us? • Management of all the PV related activities for a Biotech company Our team hold a flexible skill set ranging from including case processing, safety reports and provision of a qualified strategy to operational execution, as well as person in PV. leading and managing projects.