Pharmacovigilance Consultant
Pharmacovigilance Consultant
Posted on :
23-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-08-2025
Job Description
Why Join Axians European Institutions Team
Multicultural Environment: You will work alongside professionals from all over the world fostering a diverse and enriching workplace.
Diverse Projects:Engage in impactful projects with cutting-edge technological advancements facilitated by European Institutions.
Skill Development: Work in a knowledge-driven environment where youll continually develop both technical and professional skills through exposure to complex projects.
Long-term Opportunities: Our partnerships with European Institutions offer stable long-term roles where you can make a real difference on a European scale.
Contributing to European Initiatives:Make a meaningful impact on regional and global challenges.
We are seeking a Pharmacovigilance Consultantto join our remote team in Portugal.
Ready to embark on an exciting journey with us
Apply now to join a vibrant team contributing to technological advancements in European Institutions. Please send your application to with the subject .
Multicultural Environment: You will work alongside professionals from all over the world fostering a diverse and enriching workplace.
Diverse Projects:Engage in impactful projects with cutting-edge technological advancements facilitated by European Institutions.
Skill Development: Work in a knowledge-driven environment where youll continually develop both technical and professional skills through exposure to complex projects.
Long-term Opportunities: Our partnerships with European Institutions offer stable long-term roles where you can make a real difference on a European scale.
Contributing to European Initiatives:Make a meaningful impact on regional and global challenges.
We are seeking a Pharmacovigilance Consultantto join our remote team in Portugal.
Responsibilities:
- Registration of various external stakeholders (Pharmaceutical Regulatory Authorities (PRAs) Marketing Authorization Holders (MAHs) trial sponsors non-profit organizations/institutions and IT service providers) in the following systems:EudraVigilance HumanandEudraVigilance Veterinary (EV).
- Registration of PRAs users and signatories in theEudraGMDPsystem.
- Ensure correctend-to-end registrationin EV and EudraGMDP.
- Evaluate individual cases to ensure they are created in accordance with the relevant standard requirements of the Agency.
- Ensure that issues related to EV and EudraGMDP registration are resolved and if necessary escalate system issues to the relevant Agency team.
- Provide support to external stakeholders in the following areas:
- Adverse reaction submission obligations
- Safety and product reporting as defined in EU legislation including Article 57
- Various transmission modes for submitting information via EV
- Registration requirements in EV and EudraGMDP for PRAs MAHs and trial sponsors
- Liaise with administrative and operational staff from PRAs and the pharmaceutical industry as well as with various internal Agency teams to manage and coordinate registration processes.
- Quality management and maintenanceof registration data managing data in existing EudraVigilance registration profiles and in the Agencys user and organization management portal.
- Screening and verification of various confidential documents required as part of established registration processes.
- Evaluate overall work performed using the Agencys statistical data analysis tools.
- Ensure the robustness of follow-up procedures and that they are properly followed.
- Use sound judgment to escalate and seek advice from Agency management when the quality or quantity of work performed falls below agreed thresholds.
- Act as the main contact for internal and external queries related to the EV and EudraGMDP registration process.
- Support continuous improvement by identifying and implementing process improvements/simplifications in line with business requirements.
Requirements:
- Experience withEudraVigilance Human & VeterinaryandEudraGMDPsystems.
- Knowledge ofEU pharmacovigilance legislation includingArticle 57.
- Strong skills instakeholder coordinationdata registration anddocument verification.
- Ability to manageinformation governancequality control andprocess improvement.
- Fluent inEnglish; Portuguese is a plus.
- Based inPortugal(remote role).
Ready to embark on an exciting journey with us
Apply now to join a vibrant team contributing to technological advancements in European Institutions. Please send your application to with the subject .
Required Experience:
Contract
Employment Type
Full Time
Key Skills
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