Pharmacovigilance outsourcing services

Pharmacovigilance services: together for the public health protection

We manage post-marketing and pre-marketing Pharmacovigilance activities for pharmaceutical companies that need complete and timely outsourced services to implement and maintain a pharmacovigilance system in accordance with the current legislation. We also take care of the vigilance on Medical Devices (Materiovigilance), Cosmetics (Cosmetovigilance) and Phytotherapy Products (Phytovigilance).



Safety monitoring in the use of marketed drugs

The systematic collection, processing and evaluation of suspected adverse reactions to authorised medicinal products, allows us the early detection of potential signals to constantly monitor the risk -benefit ratio of the drugs. We work as Local Pharmacovigilance Contact Person for companies that entrust us with the management of their Pharmacovigilance system, taking care of every aspect and procedure of post-marketing surveillance.

With speed and accuracy we provide the:

  • Pharmacovigilance System Master File (PSMF) drafting and updating
  • Standard Operating Procedure and Working Instruction drafting and updating
  • Collection, management and evaluation of Suspected Adverse Reactions (ADR: Adverse Drug Reaction) received from any source
  • Pharmacovigilance Agreements drafting with Third Parties (SDEA, PVA)
  • Monitoring of medical-scientific literature (local and international)
  • Risk Management Plan (RMP) drafting and implementation of risk minimization misures
  • Eudravigilance management: XEVMPD and ICSR
  • Drafting and notification to Competent Autorithies of periodic safety reports such as PBRER, PSUR and PADER
  • Management of Signal detection acivity (Signal detection – EVDAS)
  • Pharmacovigilance Database use
  • Audit and Inspection preparation



Focus on regulatory compliance of interventional clinical trial

Our mission is to preserve the safety of patients involved in the clinical trials providing the compliance with the current legislation at every stage of Investigational Medicinal Product (IMP). With our expertise we manage each pharmacovigilance activity of interventional clinical trials starting from Standard Operating Procedure to SAE collection until to SUSAR and DSUR notification to Competent Authorities.

Regarding the clinical trials we support for:

  • Standard Operating Procedure drafting and updating
  • Safety Monitoring Plan drafting
  • Eudravigilance management: EV Responsible Persone, Trusted Deputy, XEVMPD
  • Adverse events collection, management and evaluation (AE, SAE)
  • SUSAR notification to Competent Authorities
  • Development Safety Update Report (DSUR) editing and notification to Competent Authorities
  • Audit and Inspection preparation



Materiovigilance: patient health and safety in the first place

The Materiovigilance is the framework that manage and control the proper functionality of medical devices and the detection and management of communications regarding alterations and incidents occurring after the marketing. The aim of the medical device vigilance is to guarantee health and security of patients and users. According to the current regulation, JSB experts collaborates with all the players involved in the process for the fulfilments required, managing the following activities on behalf of our clients:

  • Working as Responsible person
  • Standard Operating Procedures drafting and updating on Materiovigilance activities
  • Implementation of Post-marketing Surveillance (SSPC)
  • Support for manufacturers/and authorized representativesfor the management and notification of Incidents (including the follow-up phase and any Corrective Actions) that occurred in EU and non-EU territory
  • Support for manufacturers/ and authorized representativesfor the management of post-market and pre-markete clinical investigations



Cosmetovigilance: collecting and reporting of undesirable effects

We manage all the activities regarding the collection, casuality assessment, managing and monitoring of undesirable effect reports that arise from the use of cosmetics, with the aim of facilitating post-marketing surveillance and protecting the consumer health . As Responsible Person, we promptly identify the onset of problems relating to cosmetic products safety, managing, reporting and drafting Standard Operating Procedures on Cosmetovigilance activities, collecting and managing the reports, and the following notification to Competent Authorities and updating the Product Information File.