– Reception and documentation of cases
– Analysis of the notification to verify the validity of the cases and determine the serious or non-serious nature
– MedDRA entry and coding of events or incidents in the dedicated database (Safety Easy, ARISg, Argus, etc.)
– Medical evaluation of cases and rating of imputability (WHO-UMC system and French imputability method, imputability method for cosmetic products, etc.) and unexpected or expected nature
– Reporting of adverse effects (SARs, SUSARs, SUEs ,..) or incidents to the competent authorities (ANSM, EMA via Eudravigilance, etc.) in compliance with regulatory deadlines

 – Provide appropriate responses to the Health Authorities and collect the necessary supplements
– Participation in investigations
– Writing of ad hoc reports and investigation reports at the request of the Health Authorities

– Ensure monitoring of scientific and medical literature on electronic databases (Medline, Embase, Excerpta Medica, etc.) and on all non-indexed journals
– Monitor the evolution of French and international regulations in the field of company’s activity

– Suivre l’évolution de la réglementation française et internationale sur le domaine d’activité de l’entreprise

– PSUR/ PBRER: Periodic Safety Update Report / Periodic benefit-risk evaluation report
– ACO & CES: Addendum to the Clinical Overview & Clinical Expert Statement
– ​​DSUR: Development Safety Update Report
– RMP: Risk management plan
– SER: Safety Evaluation Report
– CPSR: Cosmetic Product Safety Report
– FSN: Field Safety Notice
– PSR: Manufacturer’s Periodic Summary Report

– Qualitative (revision of ICSRs) and quantitative (statistical analysis in databases) detection of signals
– Validation and evaluation of signals identified during vigilance activities
– Definition of possible measures to minimize the risks associated with signals
– Communicate immediately to the authorities the signals that may have repercussions on public health and the benefit-risk balance of the products in question

– Quality control over pharmacovigilance activities in compliance with SOPs, GVPs and local regulations
– Implementation and monitoring of quality indicators linked to deadlines for submission of cases and periodic reports
– Ensure initial and continuing training of employees
– Drafting and updating of procedures, operating methods, technical manuals and technical sheets
– Preparation and participation in inspections and audits
– Monitoring of the inspection report and implementation of corrective or preventive actions (CAPA)
– Updating and maintenance of the PSMF
– Monitoring of Safety Data Exchange Agreements (SDEAs)

– Answer questions from healthcare professionals and patients
– Inform healthcare professionals and patients of all changes to the safety profile of products and precautions or restrictions on use
– Promotion of the appropriate use of medications and MDs among healthcare professionals healthcare professionals and patients
– Management and monitoring of cases linked to Medical Information issues

– Equipped premises of 2000 m2 certified by the ISO 27001 standard
– Control of large call volumes
– Business Continuity Management (BCM)
– Experts in crisis communication
– Dedicated project manager