Why Is Pharmacovigilance Training Important?
Effective pharmacovigilance (PV) relies not only on systems and procedures, but also on people who fully understand their roles and responsibilities.
According to EU GVP Module I, Marketing Authorisation Holders (MAHs) must ensure that all personnel involved in pharmacovigilance activities are trained appropriately for their tasks – including internal staff, external partners, and national representatives, both within and outside the EU.
Training gaps are a frequent cause of deviations, audit and inspection findings. Targeted PV training is therefore essential to ensure operational reliability, regulatory compliance, and inspection readiness.
In many markets – especially those with limited local PV infrastructure – teams face challenges when cooperating with EU-based MAHs and aligning with global standards. My customised pharmacovigilance training programmes are designed to close that gap and build local and global compliance capability.
At the same time, EU-based companies benefit from structured PV training - whether onboarding new employees, preparing for inspections, or aligning external stakeholders. I offer tailored training solutions for both EU and non-EU settings.
Pharmacovigilance Trainings
Targeted Learning for Compliance & Operational Excellence
PV Agreements & Responsibilities
Training on understanding PV agreements, mapping contractual obligations to operational responsibilities.
Role-Based Training
Foundational and advanced training for specific roles such as Local QPPVs, and LCPs/LSOs, aligned with national and EU regulatory requirements.
Training on Local PSMFs/PSSFs
Training on the creation and maintenance of local pharmacovigilance system files where required by national legislation.
SOP- and System-Based Trainings
Guided walkthroughs of company-specific processes and systems to support SOP rollouts, onboarding, and operational implementation.
My Services – Customised PV Training Solutions
I provide pharmacovigilance training that is adapted to your products, processes, regulatory framework, and team experience:
Training on GxP-Compliant Documentation
Helping your team understand how to document PV activities properly to ensure traceability and inspection-readiness.
Audit & Inspection Preparation
Focused training on regulatory inspection expectations, document control, and common pitfalls to avoid.
Refresher Trainings
Regular update sessions to reinforce changes in GVP, internal processes, or national regulations.
Delivery Formats Tailored to Your Needs
I offer flexible training formats to fit your team’s structure and requirements:
✔ Live online sessions or on-site workshops
✔ Individual training or team-based workshops
✔ Follow-up Q&A sessions and knowledge checks
✔ Customised materials adapted to your company's PV system
All training sessions are available in English or German and scheduled according to your time zone.
Your Benefits – Competence, Confidence, Compliance
✔ GVP Compliance Secured
Fulfil regulatory training requirements for all PV-relevant staff, with traceable documentation.
✔ Improved Partner Collaboration
Equip distributors, licensing partners, and service providers with the knowledge they need to fulfil their PV responsibilities.
✔ Fewer Inspection Findings
Prepare your team to perform confidently during audits and regulatory inspections.
✔ Faster Onboarding and Operational Integration
Accelerate time-to-competence for new employees or partners with targeted, expert-led sessions.
✔ Reduced Compliance Risks
Close knowledge gaps proactively and reduce the risk of deviations, findings, or inspection observations.
Need support in training your local partners or internal pharmacovigilance staff?
Let’s get your team ready to perform.
Get in touch for customised training solutions – from single sessions to full training programmes.
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