Pharmacovigilance Audit & Training Services

Pharmacovigilance audit & training services tailored to the
compliance and quality needs of MAHs and CROs.

DrugCard's Pharmacovigilance Audit Services

Internal Pharmacovigilance System Audits

Our team provides comprehensive internal pharmacovigilance audit assessment services to assess the efficiency of your pharmacovigilance system and improve it continuously for all pharmacovigilance-related activities.

Compliance Audits Against GVP, ICH, and Local Regulations

We perform an analysis of your procedures in accordance with GVP modules, ICH guidance documents, and regional legislation. This guarantees that your pharmacovigilance activities are in compliance with all legal obligations.

Vendor and Partner PV Audits

DrugCard performs structured PV audits of your vendors and partners, applying a risk-based approach and risk-based sampling to evaluate third-party compliance and identify potential risks to your PV system.

Audit Findings, CAPA Development, and Follow-Up Support

To assist with this, we develop corrective measures, support their implementation, and perform follow-ups to ensure the resolution of all identified issues and proper handling of pharmacovigilance training issues.

Pharmacovigilance Training Programs for PV Teams

DrugCard offers structured PV training programs designed to build competence across all levels of PV teams. Our training services are related to the modules of GVP, good pharmacovigilance practice principles, risk management, and other aspects that are necessary for the efficient work of the pharmacovigilance system of the company. Our training services can be used for any type of personnel, from beginners to specialists with experience.

DrugCard Platform in Numbers

121+

Countries
Medical journals coverage

2200+

Local journals
Continuously monitored

Weeks
New country Easily Added

Our Methodology: How We Deliver PV Audits and Training

DrugCard follows a structured, risk-based approach to conducting audits and delivering good pharmacovigilance practice training. Our approach involves risk assessment, audit planning, and conducting of full pharmacovigilance system assessment.

Benefits for Your Pharmacovigilance Team

Working together with DrugCard ensures tangible results when it comes to regulatory compliance, risk management, and the overall performance of your pharmacovigilance team.

Improved Regulatory Compliance and Inspection Readiness

Through our comprehensive audit process, your PV program will be aligned with the up-to-date GVP modules and ICH standards, ensuring that your organization is always ready for the inspection process and is compliant with all relevant regulations at any time.

Reduced Compliance Risks and Findings

In every project we take on, we use a risk-based approach that allows us to discover risks in your PV processes and resolve any issues that may potentially lead to significant findings in the course of external quality audits.

Stronger PV Processes and Team Competency

In addition to auditing, our course also equips your PV staff with hands-on expertise in fundamental concepts, GCP guidelines, and competencies that are necessary for the efficient operation of the pharmacovigilance process.

Sustainable Quality and Continuous Improvement

DrugCard enables the integration of internal assessment and preventive measures in your company, facilitating quality management and adaptation of your PV system according to regulatory changes.

Who These Services Are Designed For

DrugCard’s PV Audit and Training Services are meant for the MAHs, CROs, and Pharmaceutical Companies regardless of their developmental phase. Be it setting up a PV system from scratch or preparing yourself against inspections, we cater to all your requirements in terms of PV and provide you with complete assistance in meeting compliance standards.

Reasons to Choose Us for Pharmacovigilance Audit and Training

Experienced, qualified persons with deep expertise in pharmacovigilance, PV auditing, and training
Risk-based audit programme tailored to your organisation’s specific PV needs
Full coverage of GVP modules, ICH, and local regulatory requirements
Clear audit report with actionable findings and CAPA support
Proven track record in supporting MAHs and CROs across regulatory inspections and compliance programmes

Get Your PV Team Audit-Ready and Confident