Building a compliant Pharmacovigilance Quality System

  • 1° EDITION: September 30th 2024
  • 2° EDITION: March 3rd 2025
  • Online
  • Italian

Training overview

What is a Pharmacovigilance Quality System and why is it important?

According to current regulations, it is the responsibility of AIC Holders or Marketing Authorization Holders (MAHs) to put in place and maintain a Pharmacovigilance System and its quality system: a Pharmacovigilance Quality System that is adequate to detect any changes in the benefit/risk profile of authorized medicinal products.

The construction of an effective and efficient Quality System requires, first and foremost, the presence of adequate, competent resources properly trained, adequate tools and infrastructure, and also the implementation of organizational and procedural aspects, as well as periodic monitoring of their effectiveness, with identification and evaluation of Key Performance Indicators. Finally, the necessary actions must be taken to achieve the improvements and reach the expected standards. In fact, it turns out to be essential the systematic activity of “Auditing,” to be implemented in line with international standards and recalled in the same GVP, Good Pharmacovigilance Practice.

Pharma Education Center’s “The Pharmacovigilance Quality System” training course aims to examine all these key aspects, answering participants’ doubts.

Interested in Pharmacovigilance training?

Key points of the training

  • Know the relevant regulations underlying the Quality System in Pharmacovigilance
  • Identify the organizational and procedural elements for an effective PQS
  • Learn how to set up and perform an Audit
  • Putting in place and monitoring improvement actions (CAPAs)
Course Structure

09:30 – 12:30 MORNING SESSION


The FV Quality System: Organization and Governance

  • Governance (global, regional, local)
  • Key figures in Quality: roles and responsibilities
  • Management interactions with other functions
  • Interactions with the business The FV Quality System: key aspects
  • The PSMF and the Quality System
  • Effective SOP system for Pharmacovigilance
  • Documentation Management
  • Training
  • Tools (IT, facilities)

The PV Quality System: audits

  • Audits and CAPA management

Inspections The FV Quality System: performance assessment

  • Performance Indicators
  • Relationships with Management Q&A Session

The course was designed for personnel involved in the following areas: Pharmacovigilance (PV Manager, Drug Safety Manager, QPPV, Safety Officer, PVQA), Regulatory Affairs, Clinical Research, QA, Auditor.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Grazia Sirizzotti

Grazia Sirizzotti

Associate Director Country Patient Safety Lead

Graduated in Biological Sciences in 2001 from the University of Milan, Dr. Sirizzotti worked for about three years at the National Cancer Institute of Milan. She began her career in the pharmaceutical industry at Novartis Italia S.p.a’s Medical Department as a Senior Clinical Safety Associate. She then continued her career at Recordati S.p.a. where she served as Deputy to the QPPV in a Parent Company. From 2009 to 2015, she was Pharmacovigilance Manager of the Italian affiliate of Grunenthal Italia S.p.a. From 2015 to 2024, she held the position of Local Pharmacovigilance Contact at Biogen Italia S.r.l. Since 2024, she has been serving as Associate Director Country Patient Safety Lead at Gilead

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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