Outsourcing in Pharmacovigilance, why?

1. • The need for continuous updating of the current regulations
and on the standards applied by pharmaceutical Companies
• The need for an operational superstructure for the management
of the peaks in activities in compliance with the provisions of its
own Pharmacovigilance System / current regulations (GVP)
• The need to periodically check the compliance of its own
Pharmacovigilance System and its own activities of
Pharmacovigilance vs. internal KPI and the current regulations (GVP)
• The need to locate internal figures in the Company with
independent roles and with differentiated skills (FV/QA/MKT/RSS)
• The need to ensure continuity of service to respond to
the current regulations
• The need to interact and respond to the requests of the Regulatory
Authorities (ITA/EU/EXTRA EU)
• The need to implement a new Safety DB and resolve
the related issues of an IT nature
? • Pharma D&S is able to provide consultancy support
in Pharmacovigilance and organisation of “ad hoc”
theoretical/practical sessions on the hottest topics in Pharmacovigilance
• Pharma D&S has designed a model capable of ensuring the operational support
necessary for the absorption of the peaks in activity of its Customers
• Pharma D&S has Quality Assurance expertise in Pharmacovigilance and has
extensive experience in the evaluation/revision/fine-tuning of Pharmacovigilance
systems in accordance with GVP
• The technicians of the Pharma D&S Pharmacovigilance Team are able to serve in the
roles of QPPV, Local Contact Person, Deputy, QA in Pharmacovigilance, Medical
Affairs in Pharmacovigilance
• In each project, Pharma D&S involves a “technical overstaff” so as to guarantee
the continuity of the project through an internal back-up system. The QMS of Pharma
D&S also provides procedures for Disaster Recovery and Business Continuity
• For years, Pharma D&S has been offering its Customers a service of Power
of Attorney and Regulatory support in various countries, thus having a proven track
record in interaction with the Regulatory Authorities for issues of an RA/ FV/ QA nature
• Pharma D&S makes available to its Customers its own Safety DB (PcVmanager
of Extedo) and is able to provide the necessary support for incoming and outgoing
Pharmacovigilance data migration, in accordance with current legislation (GVP).
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Pharma D&S also can....
• Develop the Safety documentation: RMP, PSUR, DSUR, Addenum to the Clinical Overview
• Perform “on demand” consulting services in the context of Pharmacovigilance, engaging
Technical or Medical Affairs profiles
• Support the Companies in operational activities such as case processing, QC, medical
review, screening of the literature (indexed/local), screening of the digital media,
managing Eudravigilance, XEVMPD management, signal processing
• Review or develop the Pharmacovigilance System and the Quality System in
Corporate Pharmacovigilance, internal KPI definition, SDEA development/revision
• Develop an ad hoc back-up service on the Company’s specific needs
• Design customised Outsourcing services
• Provide a Full Outsourcing service, including QPPV roles and internal Deputies
• Define a strategic and tactical plan (risk based) of Audit in PV
• Execute System Audits, Pharamcovigilance Audits, SDEA Audits
Outsourcing in Pharmacovigilance, why? The Pharma D&S solutions
going through changes