Pharmacovigilance Consultant Lisboa

Pharmacovigilance Consultant
Lisboa
Lisboa, Lisboa, Portugal

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
- edge technological advancements facilitated by European Institutions.

Skill Development : Work in a
- driven environment where you'll continually develop both technical and professional skills through exposure to complex projects.

Long-term Opportunities : Our partnerships with European Institutions offer stable,
- 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 Consultant to join our remote team in Portugal.

Responsibilities:

Registration of various external stakeholders (Pharmaceutical Regulatory Authorities (PRAs), Marketing Authorization Holders (MAHs), trial sponsors,
- profit organizations/institutions, and IT service providers) in the following systems: Eudra
Vigilance Human and Eudra
Vigilance Veterinary (EV).

Registration of PRAs, users, and signatories in the Eudra
GMDP system.

Ensure correct
-
- end registration in EV and Eudra
GMDP.

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 Eudra
GMDP 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 Eudra
GMDP 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 maintenance of registration data – managing data in existing Eudra
Vigilance registration profiles and in the Agency’s 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 Agency’s statistical data analysis tools.

Ensure the robustness of
- 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 Eudra
GMDP registration process.

Support continuous improvement by identifying and implementing process improvements/simplifications in line with business requirements.

Requirements:

Experience with Eudra
Vigilance Human & Veterinary and Eudra
GMDP systems.

Knowledge of EU pharmacovigilance legislation, including Article 57.

Strong skills in stakeholder coordination, data registration, and document verification.

Ability to manage information governance, quality control, and process improvement.

Fluent in English; Portuguese is a plus.

Based in Portugal (remote role).