System Build
As a Contracted Pharmacovigilance Service Provider, we conduct our pharmacovigilance activities in full compliance with global and local guidelines and regulatory requirements.
Regulatory Documentation & Compliance
- Pharmacovigilance System Master File Preparation
- PV Quality Management System Setup
- Regulatory Intelligence
- Migration & Validation of Safety Data
QPPV Services
Pleksus has a network of qualified local QPPV partners in Turkey; we will draw on this network whenever you need advice and support in establishing your local QPPV network.
Post Marketing
Safety Data Collection & Case Management
- ICSR Processing & Medical Review
- Literature Monitoring
- XEVMPD/EV/MedDRA Maintenance
Regulatory Reporting & Compliance
- Preparation and submission of periodic safety reports
- Post-Authorisation Safety Studies
- Safety Communication
- Safety Variations & Reclassifications
Signal Detection & Risk Management
- Signal Detection & Management
- Health Authority Signal Requests
- Risk Management Plan (RMP)
- Monitoring & Effectiveness of Additional RMMs
- Benefit-Risk Assessments
Regulatory Intelligence
We provide up-to-date and reliable information for your strategic decision-making processes by analyzing legislation, guidelines, and regulatory updates published by national and international health authorities.
Literature Monitoring
It is a CFR Part 11–compliant system developed for pharmacovigilance literature screening processes, which periodically searches the Turk Medline and PubMed indexes for adverse event reports using predefined keywords, generates reports of the search results, and stores them as an archive.
Safety Database
Adverse events are collected, assessed, followed up, and stored on a single platform through a validated, web-based application that meets the safety database requirements specified in the "Guideline on the Principles and Procedures of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders" issued by the Turkish Medicines and Medical Devices Agency (TİTCK), which entered into force on 24.01.2024, and that provides output in ICH E2B(R3) format together with signal management for adverse reaction assessment.
Product License
We carry out all necessary pharmacovigilance activities during the product licensing process.
Audit Readiness
Pleksus Pharmacovigilance Services and Clinical Trials provides consultancy services to meet the current legislative requirements with its experienced employees in all pharmacovigilance fields.
- Establishment of Pharmacovigilance Quality System
- Creation / Review of Standard Operation Procedures and Related Documents
- Compliance Management Activities
- Pharmacovigilance Trainings and Training System
- Preparation and Follow-up of Deviation, Corrective and Preventive Action Plans
- Change Control
- Pharmacovigilance Audits
- Support During, Before, and After Authority Inspections
- Subcontractor Audits
- Preparation of Periodic Benefit Risk Evaluation Reports
- Preparation of Risk Management Plans
- Preparation of Pharmacovigilance System Master File
- Preparation and Follow-up of Security Data Exchange Agreements
- Signal Management and Risk Minimization Activities
- Safety Variations and Emergency Safety Issues
- Managing Quality Complaints and Medical Information Requests Processes
- Risk Minimization Activities: Additional Monitoring Activities, Patient Support Programs, Controlled Access Program
Training
As Pleksus Pharmacovigilance Services and Clinical Trials, we provide training through our e-learning platform.