Adverse Event Reporting
In a constantly evolving technical and regulatory environment, Efor teams provide their expertise in pharmacovigilance, materiovigilance, reactovigilance and cosmetovigilance of marketed products.
Our expertises PVMV
Our vigilance experts assist manufacturers in the implementation and upgrade of their quality management system, including:
- Writing procedures and associated forms
- Preparation or maintenance of the Pharmacovigilance System Master File (PSMF) and its summary
- Implementation of bibliographic monitoring
- Team training through our certified training organization
Data management and trend analysis
Safety reports drafting
In the pharmaceutical industry:
- Writing of DSUR/PSUR/PBRER/PADERs
- Writing of the Risk Management Plan (RMP) and preparation of risk mitigation measures
In the medical device and IVD industry:
- Writing of MIR, FSN, FSCA, periodic summary reports
- Writing of post-market surveillance plans and reports (PMS/PSUR)
- Updating risk analyses and technical documentation accordingly
Backlog management – Task force
In this regard, we work on limiting the impact in terms of workload for internal teams, to allow our clients to fully optimize their resources. Efor offers the creation of a task force dedicated to reducing backlog complaints and regularly monitoring the progress through dashboards and KPIs.
StructuringStructuring post-market surveillance activities for medical devices is an important challenge. Our collaborators provide their expertise for the management of vigilance cases, from reception to closure, including the necessary investigation for the processing of these incidents.
TrendsThe requirements for post-market follow-up of medical devices also involve other activities besides vigilance, such as drafting PMS/PMCF plans and PMS/PSUR/PMCF reports. Today, thanks to the work of our Technical Department, Efor has been able to offer clear and adapted tools to ensure the collection and analysis of trends in all PMS data.
TrainingsThe requirements related to post-market surveillance of healthcare products are numerous and constantly evolving. Thanks to our training platform, Tree, we have provided our clients with tailored training programs to enhance their understanding of these requirements, and consequently implementing pertinent and pragmatic PMS/CPMS measures.
BacklogBy assembling a team of ten experts in less than two weeks, we successfully created an offer for a project to reduce the complaint backlog of a client within a three-month deadline.
OptimizationOur teams of consultants strengthen our clients’ teams to ensure optimized management of vigilance cases, from their reception to closure.
« With our position as a leader in the field of health product safety, it is natural that we address our clients’ vigilance needs. »
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