Pharmacovigilance – Quality & Vigilance

Pharmacovigilance Compliance

At Quality and Vigilance, we are proud in providing quality services in Pharmacovigilance (PV) as well as bespoke auditing services refer to tailored or customized audit solutions designed to meet the specific needs and requirements of organisations. It involves customized, and client-centric approach which considers the unique characteristics of business requirement, its risks, and complexities as well as patient safety.

PV Process audits

Adverse Event (AE) case processing
Risk Management Plan (RMP)
Literature services
Aggregate report e.g. PADER, PBRER/PSUR, DSUR
US NDA/BLA/PMA Annual Report
PV Database audit (including CSV components)
Pharmacovigilance System Master File (PSMF)
Qualified Person for Pharmacovigilance office
E2B and non-E2B ICSR submission
PV Agreements/SDEA process

Internal audits

Country Organization audits
Global PV organization audit
Regional PV office
Regional Regulatory Affairs audit
Medical Affairs office audit
Global/regional/local commercial department audit

External audits

Inspection Support

Preparing logistics
Pre-Inspection preparation
Compliance assessment
Training and Educating to staff
Document review
Corrective/Immediate Action planning
Post-Inspection follow-up activities

Qualified Person for Pharmacovigilance (QPPV)

Establishing, maintaining and overseeing PV systems and processes
Acting as a single point of contact for Health Authorities for 24-hours
Answering requests from Health Authorities
Providing Health Authorities with requested information relevant to product safety

Let’s build a GxP-compliant future together.

Have a project in mind?

Partner with us to elevate your quality systems, ensure compliance, and drive meaningful business transformation.

Built with passion and purpose. Helping you grow smarter, not harder.

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