Diese Stelle ist in deinem Land nicht verfügbar.

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

Dr. Falk Pharma GmbHFreiburg, de

Vor 30+ Tagen

Stellenbeschreibung

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 Laura Höcklin at [email protected] or call 0761 1514 252 . We look forward to receiving yourapplication via our online portal .

HR department

Dr. Falk Pharma GmbH

Leinenweberstraße 5

79108 Freiburg im Breisgau