Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
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.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.