Science Driven CRO

Science Driven CRO

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Message from the Europital CMO

Europital is an international Contract Research Organization (CRO) providing a full range of services during the clinical research and development phases for the pharmaceutical, biotechnology and medical device industries and for governmental and scientific Institutes.

With our scientific mindset, methodical approach and creative, science-driven solutions, each valued member of our Europital team is dedicated to deliver the highest quality services with a high sense of project ownership as we know that the scientific value of your results defines the return on your investment.

The scientific value of study results defines your ROI.

Since the foundation of Europital in 2010, Medical Science has been at the heart of our business. As an International Full Service CRO, quality, efficiency and operational excellence drive our daily activities. At Europital, we think and act not as service providers but as a true partner to our clients where we think together, work together and achieve success together. With our Global projects, we have been able to reach all continents on the planet exchanging knowledge, appreciating differences and building lasting partnerships.

Why Europital

  • What is the key benefit Europital provides that surpasses what is already available on the CRO market?
  • For more than a decade, Europital has been successfully providing high quality Medical Management services to the pharma industry and it achieves this by being staffed mostly by experienced and quality physicians. With the critical role played by Medics in any clinical trial, our broad and high-quality medical expertise that is integrated into our full services offer, makes Europital stand apart from its competitors and will be of great potential benefit to our existing and new clients.
  • Are you looking for a reliable partner for your study who will share responsibility and accountability?
  • The team at Europital has an unprecedented sense of project ownership. We go the extra mile with our clients to ensure success.
  • Do you want to ensure the quality of your study and the robustness of your data?
  • Europital is founded on medical science, and quality is our trademark.
  • Are you seeking a work partner who understands the specific requirements for your project?
  • At Europital, we know that each study is unique, and we establish a project-specific roadmap built on efficiency, flexibility and creative thinking to ensure operational excellence.
Download the Europital eBrochure

Scientific Board

In addition to our highly qualified and experienced team, our Scientific Board comprises a group of clinical KOLs and specialized Industry Experts.

The input and advice from our Scientific Board members from specific clinical practice and industry perspectives will support paving the way towards integrating the research concept of the project into daily clinical practice.

Lazar Popovic, MD, PhD

Prof. Dr. Lazar Popovic, MD, PhD

Professor of Oncology, Faculty of Medicine, University of Novi Sad

Dr. Lazar Popovic is a Professor of Oncology, experienced researcher and practicing Oncologist. His research activities include investigating Breast cancer, Head and Neck cancer, Urological malignancies, and Lymphoma. Dr. Popovic is an experienced clinical investigator and has contributed to more than 14 Oncology studies in all clinical phases as either Principal Investigator or Sub-investigator. He has authored 80 scientific publications and co-authored six scientific books in the field of Oncology and Clinical Research. He is a member of various International Oncology Associations and has also served as the Editor-in-Chief for the Archive of Oncology journal.

Kevin McAllister, PhD, MDA

Kevin H. McAllister, PhD, MBA

Neuroscience Expert

Kevin McAllister is a seasoned researcher and pharmaceutical professional with over 30 years of experience in the pharmaceutical industry. Kevin joined the preclinical nervous system research department of Sandoz and has held a variety of positions including Executive Director of Neuroscience at Novartis and Principal Medical Scientific Expert in the Neuroscience Clinical Development Franchise. Kevin is currently Managing Director of Neurenable GmbH, a company dedicated to enabling Neuroscience drug discovery and development and Chief Scientific Officer at SOM Biotech, a clinical-stage biopharmaceutical company accelerating discovery of therapies for unmet needs.  

Djodje Popovic, MD, PhD

Prof. Dr. Djordje Popovic, MD, PhD

Asst. Prof. Internal Medicine, Faculty of Medicine, Univ. of Novi Sad

Dr. Djordje Popvic is an Assistant Professor of Internal Medicine, Endocrinologist and experienced researcher. His research activities include the pathogenesis of type 2 diabetes, chronic complications of diabetes, diabetes therapy, and adipose tissue biology. Dr. Popovic is an experienced clinical investigator and has contributed to more than ten clinical studies as Investigator or Sub-investigator. He has authored 33 scientific articles and is a member of the Editorial Board of four international medical journals of internal medicine and diabetes.

Thierry Cousin, MD

Thierry Cousin, MD

Medical Expert

Dr. Thierry Cousin is a Medical Expert and pharmaceutical professional with more than 30 years of industry experience in Medical Affairs, Program Leadership and Market Access. Thierry has contributed to the development of various drugs during his tenure at Hoffmann La Roche, Servier, Pierre Fabre Institute and Aventis Pharma. He has contributed to the registration and marketing of nine major drugs with the FDA and European Medicines Agency. Dr. Thierry Cousin is currently the CMO of ECS Progastrin Thierry and also has a global vision of company needs with experience in Oncology, Hematology, Autoimmune and Infectious Diseases.

PenThu® provides a start to finish knowledge capture solution with regard to study guidance issues. No more missing information and no more wasted time!”

Dr. Mohamed El Malt, MD, PhD
CMO – Europital

PenThu®, the first Interactive Guidance Management System (IGMS) in the clinical research industry, is an intuitive platform enabling you with the means to smoothly provide study guidance and manage guidance issues across multiple projects with minimal effort, saving: time, energy and resources.

With the unique icon driven dashboard the IGMS enables you to stay on top of important issues and effortlessly navigate actionable items at a glance. PenThu® automatically prioritizes and classifies all guidance requests and questions minimizing time wasted sorting non-relevant communications. All guidance communications handled through PenThu® are automatically archived for download and review. With the customizable notification system, any urgent requests, actionable items, and updates are automatically sent by the IGMS to the designated team members ensuring timely actions.

PenThu® is developed by Europital seasoned clinical research professionals and founded on three-core principles:

  • Creating, managing and deploying all guidance resources to the entire study team
  • Providing team members global access to a searchable study-specific guidance repository with a means to request new guidance  to the Responsible Team Members
  • Overseeing, tracking and measuring the progress of the project and the performance of the team

View the PenThu® workflow.

Geographical Coverage

Regional Offices

Regional Offices

Trusted Partners

Trusted Partners

Headquarters

Belgium

Lieven Duvosellaan 15
9830 Sint-Martens-Latem
Belgium

Regional Offices

Belgium

ICC Building,
Van Rysselberghedreef 2,
9000 Ghent, Belgium

Hungary

Széchenyi István tér 7
1051 Budapest,
Hungary

United Kingdom

265 Cowley Road,
Oxford, Oxfordshire,
OX4 1XQ, UK

Trusted Partners

Australia, Thebarton

Egypt, Cairo

India, Mumbai

Israel, Rosh Haayin

Russia, Saint Petersburg

UAE, Dubai

USA, California

Looking for a New Career Opportunity?

Explore our Career opportunities to discover what it is like to work at Europital.

If you are passionate about your work, and want to grow your potential, Europital provides rewarding career opportunities. As a motivated and enthusiastic team player you will thrive at Europital and help our clients succeed in their projects, contribute to safely, quality and effectiveness of the projects for some of the world’s most innovating and urgent health needs.


Drug Safety Associate (DSA) – Oxford

Location: Oxford, United Kingdom

The DSA will be responsible for all pharmacovigilance activities, taking care of the pharmacovigilance operational activities including safety case management, aggregate reporting and pharmacovigilance agreements. The job responsible person will ensure that all ongoing Pharmacovigilance activities will be conducted in line with the company policy, SOP’s strategies and adhering to health authorities’ regulations. The Drug Safety Associate (DSA) will report to the Director Pharmacovigilance

Roles and Responsibilities:

  • Provides safety support and surveillance throughout the product lifecycle (Pre- / Post-authorization).
  • Oversight of day to day safety monitoring activities and safety operations for all investigational and marketed products
  • Having a well- developed experience for ensuring compliance of pharmacovigilance system and its quality system via good compliance Management and gap analysis
  • Ensuring oversight of the company vigilance system in pre- and post-authorization phases and adhere to company strategic plans, ensuring cost-effectiveness.
  • Responsible for the day to day functions such as safety case management (AEs / SAEs / SUSARs) including data triage and case validation assessment, data processing in the safety database (Data entry and MedDRA & WHODD coding)
  • Fulfilling expedited safety case (SAEs / SUSARs) reporting requirements for ICH & EMA & FDA and local health authorities.
  • Initiating the required communications of relevant safety profile products’ information to internal stakeholders / collaborates and with the co-license business partners.
  • Effective participation in the project related team meetings, tele-conferences, and any other ad-hoc safety meetings whenever required.
  • Maintaining Safety Data exchange agreements (SDEAs) and SLA with co-license partners, distributers and local safety units.
  • Initiating Requests for follow up safety case-relevant information.
  • Capable to develop and manage the literature search strategy and validating safety cases for reporting or to refer to the aggregate reports,
  • Preparation of safety aggregate reports such as DSUR, RMP, PRBER, PAERs, CSR and the clinical part of dossier for regulatory submission and documentation management.
  • Responding to queries from Health Authorities (HA), authorized Representatives and safety partners.
  • Performing timely safety data reconciliation.
  • Ensure active collaboration with external and internal stakeholders, fulfilling the ongoing projects’ requirements.
  • Develop internal procedures, working instructions including Templates and Forms.
  • Fulfilling good documentation practice by appropriate managing project-relevant documentation.

Requirements:

  • Life Science degree (pharmaceutical sciences, biomedical sciences).
  • Prior work experience in the field of pharmacovigilance and drug safety in pharmaceuticals or in CRO organizations
  • Good working knowledge of Pharmacovigilance regulations and relevant health authorities’ regulations.
  • Well-established working experience in safety case management (SAEs / SUSARs) and data entry in safety database (Arisg and / or Argus) and Safety case submission to EMA to FDA.
  • Previous working experience in signal detection and Risk management, applying appropriate tools and methodologies is a plus.
  • Good Knowledge of medical terminology: MedDRA, Who Drug dictionary.
  • Fluent in English Language and other languages is a plus.
  • good computer skills including MS Windows, Word, Outlook

Preferred competencies:

  • High sense for quality, accuracy and details-oriented.
  • Solid analytical and problem-solving skills.
  • Good communications skills with other stakeholders.
  • working with priority, can demonstrate working independently.

How to apply

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