Pharmacovigilance Services

Pharmacovigilance System Setup

A robust pharmacovigilance system is essential for meeting regulatory requirements and ensuring effective safety management throughout the product lifecycle.

We support Marketing Authorisation Holders in establishing a compliant, practical and inspection-ready pharmacovigilance system, tailored to their organisation, product portfolio and regulatory responsibilities.

Our support can include:

• Design and implementation of the Pharmacovigilance System
• Definition of PV roles, responsibilities and workflows
• Development and implementation of PV procedures and SOPs
• Development, maintenance and review of the Pharmacovigilance System Master File (PSMF)
• Pharmacovigilance training for employees and relevant stakeholders
• Establishment of interfaces with partners and service providers
• Implementation of safety reporting and escalation processes
• Support with PV Quality Management System requirements
• Preparation for audits and regulatory inspections

Whether you are preparing for your first Marketing Authorisation, expanding your portfolio or strengthening an existing PV system, we provide the expertise, training and practical support needed to establish and maintain a robust pharmacovigilance system and PSMF.

Every Marketing Authorisation Holder (MAH) in the EU is required to have access to a qualified EU Qualified Person for Pharmacovigilance (EU QPPV) who provides oversight of the pharmacovigilance system and supports continuous regulatory compliance.

We provide experienced EU QPPV and Deputy EU QPPV services, tailored to your organisation, product portfolio and pharmacovigilance setup.

Our services include:

• EU QPPV and Deputy EU QPPV appointment
• Oversight of the Pharmacovigilance System
• Availability to competent authorities on a 24/7 basis
• Oversight of the safety profile and benefit-risk balance of medicinal products
• Review and oversight of key PV documents and regulatory submissions
• PSMF oversight and compliance
• Signal and safety issue oversight
• Support during pharmacovigilance audits and inspections
• Regulatory intelligence and advice on PV requirements

Whether you require a fully outsourced EU QPPV function or additional QPPV support, we provide the expertise and continuity needed to maintain an effective and compliant pharmacovigilance system.

Navigating local pharmacovigilance requirements requires in-depth knowledge of national regulations, procedures and competent authority expectations.

We provide local pharmacovigilance expertise and National Contact Person support in the Netherlands, helping Marketing Authorisation Holders meet their national PV obligations while ensuring effective coordination with their EU pharmacovigilance system.

Our services include:

• National Contact Person for Pharmacovigilance support
• Local pharmacovigilance expertise and regulatory guidance
• Support with requirements of the Dutch competent authorities
• Local literature monitoring and safety information management
• Coordination with the EU QPPV and global PV organisation
• Support with local safety issues and regulatory requests
• Audit and inspection support
• Monitoring of relevant changes in Dutch PV requirements

Whether you require ongoing local representation or additional expertise for specific pharmacovigilance activities, our team provides practical, reliable support tailored to your organisation and product portfolio.

Effective Medical Affairs connects scientific evidence with clinical practice, ensuring that medical information is accurate, relevant and communicated responsibly throughout the product lifecycle.

We provide flexible Medical Affairs support tailored to your organisation, product portfolio and business needs. Whether you require ongoing Medical Affairs expertise or additional support for specific projects, our experienced professionals help translate scientific and medical knowledge into practical, compliant activities.

Our Medical Affairs support can include:

• Development and implementation of Medical Affairs strategies and plans
• Medical and scientific review of materials
• Medical information and management of medical enquiries
• Scientific communication and educational materials
• Literature review and scientific evidence monitoring
• Support with publications and scientific content
• Medical training for internal teams
• Support for advisory boards and scientific meetings
• Cross-functional support for Regulatory Affairs, Pharmacovigilance and Commercial teams
• Medical input throughout the product lifecycle

Whether you are preparing for launch, expanding your portfolio or strengthening your existing Medical Affairs capabilities, we provide the scientific expertise and practical support needed to ensure high-quality, compliant and effective medical activities.

Systematic literature screening is an important part of pharmacovigilance, helping to identify Individual Case Safety Reports, new safety signals and other relevant safety information from published sources.

We provide worldwide and local literature screening services tailored to your products, active substances and regulatory responsibilities.

Our services include:

• Worldwide scientific literature screening
• Local literature screening
• Identification of potential ICSRs and relevant safety information
• Screening for emerging safety signals
• Review and assessment of relevant publications
• Documentation and traceability of search activities
• Follow-up and case processing of identified safety reports, where applicable
• Support with literature search strategies and search terms
• Monitoring in accordance with applicable regulatory requirements

Whether you require global literature surveillance, local market screening or both, our team ensures a structured and compliant approach to identifying relevant safety information throughout the product lifecycle.

Regular pharmacovigilance audits are essential to assess the effectiveness of your PV system, identify compliance gaps and ensure continued readiness for regulatory inspections.

We provide independent, risk-based pharmacovigilance audits tailored to your organisation, product portfolio and regulatory responsibilities. Our audits focus not only on identifying findings, but also on providing practical recommendations to strengthen your PV system.

Our audit services include:

• Pharmacovigilance System and process audits
• Affiliate and local PV audits
• Vendor and service provider audits
• Pre-inspection and inspection-readiness audits
• Risk-based audit planning
• Audit report preparation and classification of findings
• CAPA review and follow-up
• Support with remediation and continuous improvement

Whether you require a routine PV audit, vendor assessment or inspection-readiness review, our experienced auditors help you identify risks early and maintain a robust and compliant pharmacovigilance system.

Timely and accurate handling of safety reports is a core pharmacovigilance responsibility. We provide comprehensive Individual Case Safety Report (ICSR) management, ensuring that safety information is processed consistently and in accordance with applicable regulatory requirements and reporting timelines.

Our services include:

• Receipt and assessment of adverse event and adverse reaction reports
• Case validation, data entry and processing
• Medical review and causality assessment
• Follow-up for additional safety information
• Coding using MedDRA and WHO Drug terminology
• Seriousness and expectedness assessment
• Preparation and submission of ICSRs to EudraVigilance and competent authorities
• Case reconciliation and quality control
• Management of special situations, including pregnancy, medication errors and lack of efficacy, where applicable

Whether you require support with individual cases or fully outsourced ICSR management, our experienced team ensures high-quality case processing with a strong focus on compliance, accuracy and patient safety.

Effective risk management is essential to ensure that the benefits of a medicinal product continue to outweigh its risks throughout the product lifecycle.

We provide expert support with the development, maintenance and implementation of Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs), in line with applicable EU pharmacovigilance requirements.

Our services include:

• Preparation and review of RMPs
• RMP updates throughout the product lifecycle
• Development and implementation of additional RMMs
• Preparation and review of educational materials
• Effectiveness evaluation of RMMs
• Support with regulatory authority comments and requests
• Alignment of RMPs with emerging safety information
• Regulatory and strategic advice on risk management activities

Whether you need support for a new Marketing Authorisation application, an RMP update or the implementation of additional risk minimisation measures, we help ensure that product risks are appropriately identified, characterised and managed.

Periodic Safety Update Reports (PSURs) are essential for the ongoing evaluation of a medicinal product’s safety profile and benefit-risk balance throughout its lifecycle.

We provide comprehensive support with the preparation, review and management of PSURs, in accordance with applicable EU pharmacovigilance requirements and reporting timelines.

Our services include:

• PSUR preparation and medical writing
• Collection and evaluation of relevant safety data
• Benefit-risk evaluation
• Signal and safety issue assessment
• Review and quality control of PSURs
• EU QPPV review and oversight
• Monitoring of PSUR requirements and submission timelines
• Support with PSUSA procedures and regulatory authority requests
• Support with PSUR submission

Whether you require full PSUR preparation or expert review and support, our team ensures high-quality periodic safety reporting with a clear focus on regulatory compliance and continuous benefit-risk evaluation.

Effective signal management is essential for the continuous monitoring of a medicinal product’s safety profile and benefit-risk balance. Potential new risks must be identified, evaluated and managed in a timely and systematic manner.

We provide comprehensive signal detection and management services in accordance with applicable EU pharmacovigilance requirements.

Our services include:

• Signal detection from relevant safety data sources
• EudraVigilance monitoring and review
• Signal validation, confirmation and prioritisation
• Medical and scientific assessment of potential safety signals
• Signal evaluation and documentation
• Ongoing monitoring of identified safety concerns
• Recommendations for appropriate regulatory or risk-minimisation actions
• EU QPPV review and oversight
• Support with regulatory authority requests and signal procedures

Whether you require ongoing signal management or support with the assessment of a specific safety concern, our team provides a structured and scientifically robust approach to identifying and managing emerging safety information.

Accurate and up-to-date medicinal product information in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is an important regulatory requirement for Marketing Authorisation Holders in the EU.

We provide comprehensive XEVMPD maintenance and submission support, helping ensure that medicinal product data remains accurate, complete and compliant with applicable requirements.

Our services include:

• Creation and submission of new XEVMPD product entries
• Maintenance and updating of existing product information
• Submission of variations and other relevant changes
• Management of Marketing Authorisation transfers and withdrawals
• Data review and quality control
• Monitoring and resolution of XEVMPD acknowledgements and validation issues
• Support with XEVMPD data reconciliation
• Regulatory guidance on XEVMPD requirements

Whether you require ongoing XEVMPD maintenance or support with specific submissions and updates, our team helps keep your medicinal product data accurate, compliant and up to date.