We are currently looking for a Drug Safety Associate (Infrastructure and data Management) to join our Global Drug Safety Technologies team. Reporting directly to the Head Drug Safety Infrastructure and Data Management, you will be responsible for the coordination of the ARIS Global Managed Services team and other members of GDS Technologies. You will perform data management activities 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
Coordinate 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 PV infrastructure systems (e.g. 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 in a Life Sciences field in addition to the following experience:
Bachelor degree in pharmacovigilance / other life sciences / data management or information systems related sciences (Master degree preferred)
2-4 years’ working experience in post marketing surveillance / drug safety
2-3 years’ working experience with validated drug safety databases, data management field including: EudraVigilance, E2B, custom reports, validation
Good knowledge of pharmacovigilance regulations
Fluency in English
Affinity towards automation and new technologies such as RPA and Machine Learning
Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook); experience with MS SharePoint, Cognos and SQL is preferred
Experience in drug safety database application maintenance, preferably ARISg
Experience with computerised systems validations (GAMP 5), Quality
You have strong communication skills orally and in writing and good analytical skills. You have good life science and pharmaceutical knowledge, with substantial knowledge in drug safety. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. Additionally, you have a proactive and problem-solving attitude. You are a team player and are able to maintain good working relationships, such as coordinating with service providers and worldwide partners. You work in line with the Vifor Pharma values, take responsibility for your tasks and are committed to deliver results.
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day. Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.
What you can expect of us
As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.
Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
Flexible workplace environment, home office opportunities, competitive vacation entitlement
Attractive ﬁnancial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.