PV 2023

Pharmacovigilance Services Overview.

Arriello’s Pharmacovigilance Services
A Comprehensive Drug Safety Solution.

We’re your trusted partner for comprehensive pharmacovigilance solutions. Our experienced drug safety team provides consultancy support with tailored solutions throughout the lifecycle of your pharmaceutical products.

Whether you are in the early stages of clinical safety, seeking approval, or managing an established global product portfolio, Arriello is here to guide and help you navigate the dynamic regulatory landscape on your behalf.

Understanding Your Unique PV Challenges 

Recognizing that no two products or organizations are alike, Arriello’s approach to pharmacovigilance (PV) is rooted in the understanding that each PV system must be as unique as the products and organizations it supports. Our highly experienced team is committed to providing consultancy in best practice and delivering a pragmatic, compliant, and customized pharmacovigilance solutions tailored to your specific organizational needs.

PV Overview

Holistic Support Across Different Stages 

Arriello’s commitment begins with your first contact, focusing on building a partnership founded on trust, operational excellence, and timely delivery. Our integrated services in PV, quality and compliance, and regulatory affairs ensure a seamless collaboration that adapts to the evolving needs of your pharmacovigilance system and associated stakeholders.

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Three Core Service Areas, One Cohesive Solution 

The strength of Arriello lies in the integration of our three core service areas: pharmacovigilance, regulatory affairs, and quality & compliance. This integration empowers us to evolve our service offerings in harmony with your changing requirements. Our robust Quality Management System (QMS) and project governance structure enable our experts to assess your current needs while anticipating future demands. This strategic approach allows us to provide a tailor-made pharmacovigilance solution that not only adapts over time but is also deeply rooted in specialist knowledge and meticulous strategic planning. 

Ensuring Long-Term Success Through Transparency 

At Arriello, we consider transparent communication a trademark of our service. We believe that open and clear communication is essential for your long-term success, as well as ours. By fostering a partnership based on trust and reliability, we aim to build a relationship that withstands the test of time. 

Pharmacovigilance System Requirements – An Overview: 

QPPV:

Ensure compliance by monitoring the health of your PV system and of the safety data managed within the system. Our QPPVs can provide guidance and support from the point of MAH submission development, through approval and commercialization and into ongoing lifecycle maintenance.

QPPV Services & Pharmacovigilance Oversight

EudraVigilance Reporting

Pharmacovigilance System Master File (PSMF) Management

SPOR Data Management & Compliance Solutions

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Local Pharmacovigilance (LPPV):

Navigate global pharmacovigilance requirements with expert guidance. Ensure compliance with international regulations and local pharmacovigilance practices.

Local Person for Pharmacovigilance | Local Safety Officer

ICSR Case Management & Pharmacovigilance Services

Literature Monitoring & Signal Detection for Pharmacovigilance

 

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Safety Data Management / Adverse Event Management: 

Adverse Event Reports throughout the product lifecycle (from clinical trials and post marketing) are the foundation of product safety. Robust case management and MedDRA coding procedures enable you to gain actionable insights from your pharmacovigilance data to make informed decisions about drug safety and ensure appropriate risk management and risk mitigation strategies are implemented.

Effective capture and management of adverse event and special situation reports (e.g. pregnancy, off label use) are a key part of any pharmacovigilance system.

Serious Adverse Event (SAE) & SUSAR Management Services

Art. 57 (xEVMPD) Compliance & Pharmacovigilance Services

ICSR Case Management

Scientific Literature Monitoring for Drug Safety

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Signal & Benefit-Risk Management:

Development and implementation of Benefit: Risk Methodologies and Signal Detection Processes. Management of Signal Detection activities and the assessment of safety data from all sources.

Drug Safety Signal Detection & Management Services

Benefit-Risk Management (RMP) & REMS Development Services

Drug Safety Physician Services: Benefit-Risk Assessment

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Medical Writing:

Craft compelling and compliant safety narratives for regulatory submissions. Clearly and concisely communicate safety information to regulators and healthcare professionals: Including Risk Management plans and a wide range of aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to the Clinical Overviews (ACOs).

Post-Market Safety Monitoring: Aggregate Reports for Pharma

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Drug Safety Database:

Optimize your pharmacovigilance processes with proven Veeva Vault Safety database technology. Automate submissions to improve reporting compliance and enhance  data quality and assessment with a robust pharmacovigilance database system.

Centralized Drug Safety Data Management

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Regulatory Intelligence:

Stay ahead of the curve with the latest regulatory updates and trends. Proactively adapt your pharmacovigilance practices to meet evolving regulatory requirements. 

Global Regulatory Intelligence & Pharmacovigilance Support

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Click an area to see the countries where we operate…

European and Russian coverage
Albania
Austria
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kosovo
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Moldova
Montenegro
Netherlands
Northern Macedonia
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Asia
Armenia
Azerbajan
Bahrain
Bangladesh
Brunei Darussalam
China
Hong Kong
India
Indonesia
Iran
Iraq
Israel
Japan
Jordan
Kazakhstan
Kuwait
Kyrgyzstan
Lebanon
Macao
Malaysia
Mongolia
North Korea
Oman
Pakistan
Palestine
Philippines
Qatar
Saudi Arabia
Singapore
South Korea
Syrian Arab Republic
Taiwan
Tajikistan
Thailand
Turkey
Turkmenistan
UAE
Uzbekistan
Vietnam
Yemen
Oceania / Pacific
Australia
New Zealand
South America
Argentina
Aruba
Bolivia
Brazil
Chile
Colombia
Costa Rica
Curaçao
Dominican Republic
Ecuador
El Salvador
Falkland Islands
French Guiana
Guatemala
Guyana
Honduras
Nicaragua
Panama
Paraguay
Peru
Puerto Rico
Suriname
Trinidad & Tobago
Uruguay
Venezuela
North America
Bahamas
Barbados
Belize
Canada
Jamaica
Mexico
USA
Africa
Algeria
Botswana
Burkina Faso
Cameroon
Congo
Egypt
Ethiopia
Gabon
Ghana
Guinea
Kenya
Libya
Madagascar
Malawi
Mali
Mauritania
Mauritius
Morocco
Mozambique
Namibia
Nigeria
Rwanda
Senegal
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zimbabwe
North & Central America South America Africa Oceania & Pacific Europe & Russia Asia
European and Russian coverage

Albania
Austria
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kosovo
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Moldova
Montenegro
Netherlands
Northern Macedonia
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom

Asia

Armenia
Azerbajan
Bahrain
Bangladesh
Brunei Darussalam
China
Hong Kong
India
Indonesia
Iran
Iraq
Israel
Japan
Jordan
Kazakhstan
Kuwait
Kyrgyzstan
Lebanon
Macao
Malaysia
Mongolia
North Korea
Oman
Pakistan
Palestine
Philippines
Qatar
Saudi Arabia
Singapore
South Korea
Syrian Arab Republic
Taiwan
Tajikistan
Thailand
Turkey
Turkmenistan
UAE
Uzbekistan
Vietnam
Yemen

Oceania / Pacific

Australia
New Zealand

South America

Argentina
Aruba
Bolivia
Brazil
Chile
Colombia
Costa Rica
Curaçao
Dominican Republic
Ecuador
El Salvador
Falkland Islands
French Guiana
Guatemala
Guyana
Honduras
Nicaragua
Panama
Paraguay
Peru
Puerto Rico
Suriname
Trinidad & Tobago
Uruguay
Venezuela

North America

Bahamas
Barbados
Belize
Canada
Jamaica
Mexico
USA

Africa

Algeria
Botswana
Burkina Faso
Cameroon
Congo
Egypt
Ethiopia
Gabon
Ghana
Guinea
Kenya
Libya
Madagascar
Malawi
Mali
Mauritania
Mauritius
Morocco
Mozambique
Namibia
Nigeria
Rwanda
Senegal
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zimbabwe

What our clients say about us.

Pharmacovigilance Case Studies

Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system.