Sr Regulatory Database Associate & PV Associate
+32 494 04 21 32
Description de l'emploi
The purpose of this role is two fold:
(1) 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.
- 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).
- Other specific duties and responsibilities as detailed in goals or agreed with line manager.
- 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.
- Detailed understanding of effective administrative support to a colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
- Must be able to effectively communicate in English with colleagues at all levels of the organization and external regulatory agencies.
- 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
- 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.