Global Safety Application Manager - part time 50% (m/f/d)

Dr. Falk Pharma; Freiburg im Breisgau; Vor Ort; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

Ein etabliertes Familienunternehmen im Bereich der Verdauungs- und Stoffwechselmedizin sucht nach einem erfahrenen Anwendungsmanager für ihre globale Sicherheitsdatenbank. In dieser spannenden Rolle werden Sie für die Verwaltung, Anpassung und Entwicklung von Sicherheitsanwendungen verantwortlich sein, um die Leistung und Benutzererfahrung zu verbessern. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass alle Systeme den regulatorischen Standards entsprechen. Das Unternehmen bietet eine unterstützende und respektvolle Arbeitsatmosphäre sowie vielfältige Entwicklungsmöglichkeiten. Wenn Sie eine Leidenschaft für innovative Lösungen haben und in einem internationalen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Flexible Arbeitszeiten

Mobile Arbeit

Kostenlose Getränke

Gesundheits- und Sportleistungen

Cafeteria

JobRad

Umfassendes Einarbeitungsprogramm

Qualifikationen

• Erfahrung im Anwendungsmanagement und in der Betriebsführung.
• Kenntnisse über globale Sicherheitsprozesse und ICH E2B Richtlinien.

Aufgaben

• Verwaltung der globalen Sicherheitsdatenbank und Unterstützung bei Systemvorfällen.
• Zusammenarbeit mit anderen Gruppen zur Implementierung von Lösungen.

Kenntnisse

Anwendungsmanagement

Oracle/MS-SQL Datenbanken

Argus Safety Anwendung

Kommunikationsfähigkeiten

Problemlösungsfähigkeiten

Ausbildung

Mehrere Jahre Berufserfahrung im Anwendungsmanagement

Tools

Argus Safety

Adverse Events Reporting Software

Jobbeschreibung

As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for:

Your tasks

• Application management of Dr. Falk’s global safety database incl. configuration, implementation, user workflow setup, reporting rules management, advanced conditions (in case of service provider involvement supervision and monitoring of service provider activities and other global safety applications and tools)
• Performance and support of application changes (incl. validation) after thorough impact analysis and change request in context of global safety applications
• Management and support of system incidents and problems
• Customization and development of global safety applications in order to enhance application performance and user experience
• Analysis of application-related business processes and requirements and providing expertise in business process optimization
• Collaboration with other groups (e.g. IMT, Quality, service providers) to implement solutions and ensure systems meet regulatory standards and compliance
• Support of inspection and audit preparations and responses to queries or requests
• Ensuring provision of global safety database outputs for global safety tasks like signal management and periodic report generation
• Creation and maintenance of standard operating procedures (SOPs)
• Performance of trainings for global safety employees of Dr. Falk Pharma GmbH, affiliates and service providers

Your qualification

• Several years of professional experience in the application and operation management
• Experience in working with Oracle/MS-SQOL databases, (e.g. as SME or DBA), especially Argus Safety application and other Adverse Events Reporting software are advantageous
• Knowledge about global safety processes and reporting requirements and ICH E2B guidelines would be beneficial
• It is crucial to develop and maintain expertise through continuous learning and to use this knowledge to be able to work through complex problems
• Innovate to find and reapply proven ideas and methods to resolve incidents and solve problems
• Effective collaboration with global safety managers, Information Management Technology (IMT) teams, and service providers
• Strong written and verbal communication skills to engage and influence stakeholders as needed

Your Benefits

• Supportive, respectful and appreciative work atmosphere in a small, dedicated team
• Diverse learning culture and individual development opportunities
• International and growing family business with short decision-making processes, financial independence and long-term perspective
• New work, flexible working hours and mobile working
• Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
• Comprehensive onboarding and mentoring program

If you have any questions, please do not hesitate to contact us at [e-mail] or call + 49 761 1514-102. We look forward to receiving your application via our online portal.

HR department

Dr. Falk Pharma GmbH

Leinenweberstraße 5

79108 Freiburg im Breisgau