Pharmacovigilance & Drug Safety
Comprehensive safety data management, adverse event reporting, and signal detection services that protect patient welfare and ensure regulatory compliance throughout the product lifecycle. Our pharmacovigilance professionals bring deep expertise in global safety regulations, enabling sponsors to meet their obligations across all major markets.
Vigilant Safety Monitoring Across the Product Lifecycle
MTK Pharma Services delivers pharmacovigilance solutions that span the entire product lifecycle — from first-in-human studies through post-marketing surveillance. Our safety scientists and PV specialists maintain continuous vigilance over your safety data, ensuring that emerging risks are identified early, assessed thoroughly, and communicated to health authorities within mandated timelines.
We operate within a quality management framework aligned to ICH E2E, GVP Module requirements, and regional reporting obligations. Whether you need a dedicated PV function for a single compound or a scalable safety operations team covering a global portfolio, MTK provides the regulatory knowledge, operational discipline, and technological infrastructure to keep your products and patients safe.
Comprehensive Pharmacovigilance Services
Six integrated safety disciplines that cover the full pharmacovigilance lifecycle — from individual case processing and signal detection through aggregate reporting and risk management planning.
Adverse Event Management
End-to-end case processing from initial receipt through regulatory submission, with structured triage, medical assessment, and expedited reporting workflows.
- Case intake and triage procedures
- Medical assessment and causality evaluation
- Expedited and periodic case reporting
- Follow-up management and case closure
Signal Detection & Evaluation
Systematic safety signal identification using quantitative disproportionality analysis and qualitative medical review to detect emerging risks early.
- Quantitative signal detection methods
- Disproportionality analysis (PRR, ROR)
- Medical literature surveillance
- Signal validation and prioritisation
PBRER / PSUR Authoring
Periodic benefit-risk evaluation reports and safety update reports that synthesise cumulative safety data into a balanced assessment for health authority review.
- ICH E2C(R2)-compliant PBRER authoring
- Cumulative safety data analysis
- Benefit-risk evaluation narratives
- DSUR development for investigational products
Risk Management Plans (RMPs)
Development and maintenance of risk management plans that define safety specifications, pharmacovigilance activities, and risk minimisation measures for marketed products.
- EU-RMP and US REMS development
- Safety specification authoring
- Risk minimisation measure design
- RMP update and maintenance cycles
MedDRA Coding
Accurate and consistent medical coding of adverse events, medical history, and indications using the latest MedDRA dictionary with standardised term selection.
- Adverse event and medical history coding
- MedDRA version migration management
- Standardised MedDRA Query (SMQ) application
- Coding consistency reviews and reconciliation
Safety Database Management
Configuration, validation, and ongoing maintenance of safety databases with full audit trail compliance and regulatory-ready data quality standards.
- Safety database setup and configuration
- Data migration and validation
- User access management and audit trails
- Regulatory-compliant data retention
Global Safety Reporting & Submissions
Our pharmacovigilance team manages the full spectrum of regulatory safety reporting obligations, ensuring that individual case safety reports and aggregate safety documents reach the appropriate health authorities within mandated timelines across all active markets.
-
CIOMS Forms & ICSRs
Preparation and submission of CIOMS I forms and Individual Case Safety Reports in E2B(R3) format for expedited reporting to health authorities within 7- and 15-day regulatory timelines.
-
EudraVigilance Submissions
Electronic submission of ICSRs to the European Medicines Agency via the EudraVigilance gateway, with full compliance to EU pharmacovigilance legislation and GVP Module VI requirements.
-
FAERS Submissions
Preparation and electronic filing of adverse event reports to the FDA Adverse Event Reporting System, covering both pre-market (IND safety reports) and post-market (MedWatch) obligations.
-
Multi-Market Reporting
Coordinated safety reporting across additional regulatory jurisdictions including MHRA, PMDA, Health Canada, and TGA, with country-specific formatting and submission pathway management.
Why Choose MTK for Pharmacovigilance
Drug safety is a non-negotiable obligation with zero tolerance for missed timelines or incomplete assessments. Here is why sponsors entrust their pharmacovigilance operations to MTK.
Qualified Safety Scientists
Our PV team includes physicians, pharmacists, and safety scientists with extensive experience in medical assessment, causality evaluation, and regulatory safety science.
24/7 Case Processing
Round-the-clock safety operations ensure that serious and unexpected adverse events are triaged, assessed, and reported within regulatory timelines regardless of time zone.
Global Regulatory Coverage
Proven compliance with FDA, EMA, MHRA, PMDA, Health Canada, and TGA pharmacovigilance requirements, enabling seamless multi-market safety reporting from a single team.
Data-Driven Signal Management
Quantitative signal detection combined with expert medical review provides early identification of safety trends, enabling proactive risk management and informed decisions.
Discuss Your Safety Needs
Whether you need a full pharmacovigilance function for a first-in-class compound, signal detection support for a marketed portfolio, or aggregate report authoring for an upcoming submission deadline, our safety experts are ready to help. Contact us to explore how MTK can strengthen your drug safety operations.