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Clinical and Medical Affairs

Pharmacovigilance.

Drug safety throughout the entire lifecycle. We help pharmaceutical companies implement robust, crisis-proof pharmacovigilance systems in accordance with strict European GVP guidelines.

The pharmacovigilance team discusses drug safety data at a meeting

What is pharmacovigilance? Pharmacovigilance encompasses all activities related to the detection, assessment, prevention, and reporting of adverse drug reactions. It is mandated by EU Directive 2001/83/EC and EU Regulation 726/2004 and includes QPPV services, signal detection, PSUR preparation, and risk management (RMP).

What requirements must PV systems meet?

GVP (Good Vigilance Practice) defines the binding European framework for pharmacovigilance. This presents significant compliance risks:

  • The PV system must be fully and comprehensively documented in the Pharmacovigilance System Master File (PSMF) at all times.
  • Adverse event reports to the EMA (Eudravigilance) and to national authorities must be submitted within strict deadlines.
  • According to GVP Module IX, structured signal detection and signal management are mandatory legal requirements.
  • PSUR/PBRER reports must be prepared and submitted exactly according to schedule and with the highest data quality.
Is your pharmacovigilance system fully documented in the PSMF and ready for an unannounced EMA inspection?
Specialist reviews adverse event report with a fountain pen

Our pharmacovigilance services.

We cover all critical PV functions—whether as process consultants, hands-on support specialists, or interim resources for your team.

PV System Installation & PSMF
Professional design and implementation of a comprehensive, audit-ready PV system in accordance with GVP Modules I–XVI. We handle the initial creation and ongoing maintenance of the Pharmacovigilance System Master File (PSMF).
SAE Management & Eudravigilance
Process framework for robust ICSR management: case intake, in-depth medical evaluation, coding (MedDRA), and direct reporting to EMA Eudravigilance. We ensure compliance with all statutory deadlines for SAE reporting (7, 15, and 90 days).
Signal Detection & Risk Management
Implementation of a highly efficient, structured signal detection process in accordance with GVP Module IX. In addition, we assist you in developing your Risk Management Plan (RMP) and support you through the update cycles in accordance with EMA requirements.
PSUR / PBRER Preparation
Comprehensive, expert preparation of PSURs and PBRERs in accordance with ICH E2C(R2). We integrate international field data, ICSR analyses, clinical trial results, and spontaneous reports into a comprehensive benefit-risk assessment.

How does ENTOURAGE install your solar power system?

From gap analysis to ongoing safety reporting—in 5 phases.

01

PV Assessment

Evaluate the existing PV system against GVP modules. Identify compliance gaps.

02

PSMF Structure

Create or update the Pharmacovigilance System Master File. Appoint a QPPV.

03

Process Setup

Develop SOPs for case processing, signal detection, PSUR preparation, and RMP.

04

Safety Database

Configure the safety database. Record ICSRs, perform MedDRA coding, and conduct causality assessments.

05

Ongoing reporting

Create PSURs, DSURs, signal reports, and regulatory submissions during routine operations.

PV
“Pharmacovigilance is not a cost factor—it is patient protection and a regulatory requirement. An effective pharmacovigilance system identifies safety signals before they lead to product recalls.”
Pharmacovigilance Team, ENTOURAGE

Frequently Asked Questions About Pharmacovigilance & GVP.

What exactly is a PSMF?
The Pharmacovigilance System Master File (PSMF) is the most critical document for a marketing authorization holder. It provides a detailed description of the entire pharmacovigilance system, including all responsibilities, processes, IT systems, existing contracts, and ongoing pharmacovigilance activities. The PSMF must be available for immediate submission to the regulatory authority upon request.
What is a QPPV?
The Qualified Person for Pharmacovigilance (QPPV) is the key person designated by law to oversee drug safety in the EU. He or she bears sole personal responsibility for the company’s pharmacovigilance system and for ensuring compliance with all GVP requirements vis-à-vis the regulatory authorities.
What is signal detection in pharmacovigilance?
Signal detection is the systematic, ongoing analysis of all available safety data (individual case safety reports, literature data, registries). It involves actively searching for new or changing risk signals associated with a drug. GVP Module IX requires that this process be conducted in a structured manner and be extremely well documented.
Who is required to submit a Risk Management Plan (RMP)?
An RMP is mandatory for all newly authorized medicinal products within the EU, without exception. It is also required in the event of significant changes to the marketing authorization or if the EMA or national authorities explicitly request it. The RMP must be updated regularly, usually as part of the PSUR process or following the identification of new safety signals.
Does every company need its own QPPV?
Yes. Every marketing authorization holder in the EU must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is based in the EU. ENTOURAGE provides on-call external QPPVs.
How much does it cost to install a solar power system?
A gap analysis takes 3–5 consultant days. The complete PV system setup (PSMF, SOPs, Safety Database) takes 20–40 consultant days. Ongoing case processing is billed per case or on a retainer basis.

Additional expertise in clinical safety and monitoring.

Expertise

QPPV Services

Qualified Person for Pharmacovigilance as a Service.

 Expertise

Medical Writing

Clinical preparation of PSUR, PBRER, and DSUR documents.

 Expertise

Post-Market Surveillance

Post-market surveillance (PMS) for medical devices.

Your patient safety is our top priority.

Trust ENTOURAGE to build your PV systems in a way that stands up to audits and to firmly embed GVP compliance into your daily business operations without compromise.

Submit a project inquiry.

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