DRUG SAFETY ASSOCIATE (DATA MANAGEMENT) - ZURICH

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Drug Safety/Pharmacovigilance

Compagnie: Vifor Pharma

Georgia Izzat

International Talent Acquisition Specialist

+41 58 851 83 78

Conditions pour les agences de placement

Votre profil

We are currently looking for a Drug Safety Associate (Data Management) to join our Global Drug Safety Infrastructure & Data Management Team. Reporting directly to the Head Drug Safety Infrastructure & Data Management, you will be responsible for the management of the ARIS Global Managed Services team and maintain the validated state of the Drug Safety database, to ensure compliance with regulatory standards. Your tasks and responsibilities will include, but not be limited to, the following:
  • Administration of the Drug Safety database (management and maintenance of libraries, codelists, users, dictionaries) with the support of the ARIS Global Managed Services team.
  • Manage and oversee the ARIS Global Managed Services team activities (user support, incident management, configuration changes).
  • Ensure appropriate documentation of the ARIS Global Managed Services team activities.
  • Support maintenance and enhancements of all ARISg modules, ESTRI gateway etc.
  • Regularly train ARISg users (internal and contracted) on data entry conventions and validations.
  • Manage database validations and regularly screen database for discrepancies.
  • Manage the data entry conventions for safety database in line with the most recent regulatory requirements.
  • Support data cleaning activities, define major elements for regular data cleaning activities.
  • Support database querying activities (requirements definition, reports validation) monitoring the quality of data outputs and process efficiency.
  • Assist in implementation of new solutions for drug safety.
  • Support the Drug Safety Case Management team in regular process enhancements.
  • Maintain Standard Operating Procedures (business administration, data management).
The ideal candidates is holding a university degree (preferably a Masters degree) in pharmacovigilance / other life sciences / data management or information systems related sciences in addition to the following experience:
  • 2-3 years working experience in post marketing surveillance / drug safety
  • 1-2 years working experience with validated drug safety databases, data management field including: EudraVigilance, E2B, custom reports, validation
  • Good knowledge of pharmacovigilance regulation
  • Fluency in English
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook), experience with MS SharePoint, Business Objects and SQL is preferred
  • Experience in drug safety database application maintenance, preferably ARISg
  • Experience with computerised systems validations (GAMP 5), Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management is preferred
You bring good interpersonal skills with a problem and conflict solving attitude. You have strong communication skills orally and in writing and good analytical skills. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You work effectively in cross-functional teams, with the ability to develop good working relationships with service providers and global partners.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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Conditions pour les agences de placement