WE TAKE  THE
FRESH APPROACH

by nature

Home > Talents

Senior Associate European Regulatory Database Administrator / Pharmacovigilance Associate

Introductie


Our client is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, they deliver quality medicines and vaccines and supported by a range of services. Their mission is to better understand and address the real-world challenges faced by those who raise and care for animals.


Functie-informatie


AS European Regulatory Database (GRDB) Administrator / Pharmacovigilance Associate:

The purpose of this role is twofold:

(1) European, Africa and Middle East (EuAfME) Regulatory Database Administrator 

You will work closely with the GRDB Global Administrator, and other members of the core GRDB team, to ensure a high standard of data integrity within the GRDB within the EuAfME region. In this role, you will be expected to spend a significant amount of time independently: identifying, prioritising and resolving issues, providing training and support for VMRA staff and in country Regulatory Managers. 


(2) Pharmacovigilance Associate

You will work closely with the rest of the Pharmacovigilance team based in Zaventem supporting daily activities which is expected to include PSUR template preparation, sales data processing, generate PSUR line lists and other reports out of the Global Pharmaocvigilance Database, GRDB reporting, Adverse Event case importing and processing. Additional tasks as needed.


Your Responsibilities:

  • Act as the EuAfME GRDB Administrator. 
  • Work to continually maintain and improve data structure and integrity in the GRDB as it relates to EuAFME markets.
  • Support the work of the GRDB Global Administration and work collaboratively with the GRDB administrator team.
  • Act as Subject Matter Expert for European processes and procedures related to the GRDB. You will contribute, as needed, to any technical IT discussions related to the GRDB.
  • Provide training on the GRDB to country and VMRA regulatory staff. 
  • Generate PSUR templates.
  • Process sales data.
  • Generate reports and line lists out of the Global Pharmacovigilance database and other systems. 
  • Process imported Adverse Event Reports.
  • Actively collaborate with partner groups outside VMRA.
  • Participate in departmental meetings and activities (e.g. process review teams, training, team building). 



Functie-eisen


An appropriate degree in animal sciences or pharmacy.

Alternatively, demonstrated relevant experience gained with Regulatory Databases and/or Pharmacovigilance Databases preferably in an Animal Health environment.  

Ideally with knowledge of veterinary medicines / vaccines across multiple geographies and regulatory jurisdictions. 

Ideally but not essential, at least one year experience working in Veterinary / Human Pharmaceutical Regulatory Affairs. 


Technical Skills Requirements

At a minimum:

  • Detailed understanding of effective administrative support to colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
  • High level of competency using Microsoft Office suite – with demonstrated high level competence of working in Microsoft Word and Excel.
  • Must be able to effectively communicate in English with colleagues at all levels of the organization and external regulatory agencies.
  • Consistently model behaviors of accountability and ownership through approachability, excellent interpersonal, communication, negotiation and problem solving skills.
  • Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once.  
  • Attention to detail is critical to ensure that the expectations of all submissions to external agencies are met.
  • Able to demonstrate evidence of being a highly effective team player, be a problem solver with an ability to take ownership for issues with the ability to come up with creative solutions and implement them successful.
  • He/she will be able to influence without authority and support colleagues outside of VMRA as the need arises.

Aanbod


A rewarding career through the provision of a challenging role in a multicultural environment that supports continuous learning and development. The successful candidate will have ownership for key objectives and be an integral part of a successful team that delivers novel medicinal product to treat and prevent disease in animals.  


Inlichtingen bij


Not ready to apply or you still have questions?

Please give me a call on +32 10 80 71 03, I’ll be happy to give you more information!

Ready for this new challenge?!

Please send me your CV and your cover letter in a WORD format:

Carine Steurs

Recruitment eXPErt

Carine.steurs@xpe-group.net


Interested in this job?

APPLY NOW

Not what you're looking for?


Spontaneous application

Haven't found the dream job you're looking for? Submit a spontaneous application now!

Spontaneous application
*}