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