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 Laura Höcklin at personal@drfalkpharma.de or call 0761 1514 252. We look forward to receiving your application via our online portal.
