JOB DESCRIPTION AND RESPONSIBILITIES
As a result of a new project we are now seeking an Assistant for Regulatory Information Management
MAIN RESPONSIBILITIES
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Give contribution on an international project in Regulatory System Information Management, in collaboration with appropriate departments
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Work on data harmonization and interoperability across systems using XEVMPD, IDMP for EU and PQ/CMC for the US
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IDMP Data remediation
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Adapt existing processes and participation to the setup of future ones, covering the EU regulatory aspects
CANDIDATE PROFILE
ProductLife Group applies the principles of equality and diversity in the workplace and opposes all forms of unlawful discrimination.
EDUCATION & EXPERIENCE
- Bachelor Degree
- Regulatory Operation background
- Previous experience in multicultural organizations SKILLS
- Fluent English
- Knowledge of another European language is very desirable
- Knowledge of European regulatory environment including all marketing authorization types
- Knowledge of XEVMPD and IDMP
- Knowledge of Pharmacovigilance regulation
- Project Management skills
Analyste informatique
Traitement de données
Médecin généraliste (Médecin régulateur)
Pratique médicale
- Régime de travail : Temps plein de jour
- Type : A durée indéterminée