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Business Analyst Drug Safety Systems (m/w/x)
Administering, configuring, and maintaining Drug Safety Systems for pharmaceutical development. 2-3 years in pharma/life sciences, preferably GxP environments, required. Purpose-driven work supporting patient safety and innovative medicines.
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Anforderungen
- Bachelor's degree in Life Sciences, Information Systems, Computer Science, or related discipline
- 2-3 years experience in pharmaceutical or life sciences industry, preferably within Pharmacovigilance, Clinical Development, or other regulated GxP environments
- Experience gained through internships, trainee programs, or graduate roles valued
- Interest in Drug Safety and Pharmacovigilance processes
- Willingness to develop expertise in related systems and business processes
- Experience with data analysis, reporting, data visualization, and dashboarding tools
- Knowledge of database concepts, data warehousing, and data management principles
- Experience with SQL and PL/SQL desirable
- Experience with regulated business applications, such as Drug Safety Systems, Quality Management Systems, or Document Management Systems, is an advantage
- Understanding of Computer System Validation (CSV) principles and regulated environments
- Knowledge of 21 CFR Part 11 is an advantage
- Exposure to GxP environments
- Familiarity with GAMP 5 and ITIL concepts is beneficial
- Strong quality mindset with attention to detail
- Commitment to maintaining accurate documentation and compliant processes
- Strong analytical and problem-solving skills
- Ability to translate business needs into practical solutions
- Effective communication and stakeholder management skills
- Self-motivated, proactive, and eager to learn
- Collaborative team player
- Contributes to a positive and respectful working culture
- Fluent in English both written and spoken
- Knowledge of French or German is an advantage
Aufgaben
- Support administration, configuration, and maintenance of Drug Safety Systems
- Partner with business stakeholders to understand requirements
- Identify improvement opportunities for systems
- Deliver effective system solutions
- Support reporting and analytics activities
- Generate standard and ad hoc reports
- Assist with implementation of new functionalities
- Support system enhancements and release activities
- Perform system validation activities
- Conduct testing and documentation for validation
- Communicate with users during validation
- Act as primary contact for system issues
- Coordinate issue resolution with IT teams and vendors
- Provide end-user support and troubleshooting
- Deliver end-user training
- Create and maintain system documentation
- Develop system procedures (SOPs, WISs)
- Create training materials for systems
- Ensure compliance with CSV requirements
- Ensure compliance with corporate policies
- Ensure compliance with applicable regulations
- Develop expertise in Pharmacovigilance/Drug Safety processes
- Develop expertise in Drug Safety systems
- Develop expertise in industry best practices
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Purpose-driven work
- Systems supporting patient safety
- Safe use of innovative medicines
- Continuous improvement
- Diversity
- Authenticity
- Inclusion
- Pre-employment background screening
- Disclosure of interests
- Disclosure of relationships with Idorsia employees/partners
- Collaborative team
- Teamwork
- Ideas and technical expertise contribute to business processes
- Ideas and technical expertise contribute to regulated systems
- Modern ways of working
- Innovation
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Idorsia Pharmaceuticals LtdÜber das Unternehmen
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
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