Job
In dieser Position begleitest du Prozesse in der Arzneimittelsicherheit, übernimmst die funktionale Verantwortung für Module der Global Safety Platform und gestaltest Lösungsdesign, Implementierung und Validierung strategisch sowie operativ.
Deine Rolle im Team
- As Principal Business Solutions Manager, you support Patient Safety and Pharmacovigilance processes in accordance with Good Pharmacovigilance Practice.
- You will take functional ownership of defined capabilities and processes within an assigned module of the Global Safety Platform, providing strategic direction for their design, implementation, validation, and continuous evolution.
- Acting as a key interface between Patient Safety business teams and the system vendor, you will shape solutions, processes and data flows within your area of responsibility while ensuring alignment with the overall Global Safety Platform architecture and end-to-end pharmacovigilance processes.
- The role combines strategic and functional leadership with hands-on involvement in key operational activities.
- You will actively engage in requirements clarification, solution design, validation, testing and issue resolution to ensure that decisions are grounded in a deep understanding of processes, system behavior and business needs.
- As Product Owner for defined capabilities and processes within your assigned module, you will take end-to-end responsibility from business requirements and prioritization through implementation and validated use.
- This combination of functional ownership, pharmacovigilance expertise, technology understanding and strategic vendor collaboration enables you to represent your area of responsibility in cross-functional, vendor and regulatory settings.
- You will take functional and end-to-end ownership of a defined module of the Global Safety Platform, driving its design, implementation, validation, deployment and continuous evolution in line with pharmacovigilance and regulatory requirements.
- In your role as Product Owner, you will translate business and regulatory needs into requirements, set priorities and drive delivery together with business stakeholders, IT and the system vendor.
- Together with the system vendor and internal stakeholders, you will shape solution design, processes and data flows, ensuring alignment with the overall platform architecture and end-to-end Patient Safety processes.
- As part of platform changes, you will assess impacts and drive risk-based validation and testing, including test review, issue resolution, business readiness and training needs in accordance with GxP and pharmacovigilance requirements.
- For releases and enhancements, you will ensure business readiness and reliable operation, proactively managing risks, dependencies and operational issues while driving continuous improvement.
- With a focus on innovation, you will evaluate and shape the responsible adoption of emerging technologies, including AI, to improve efficiency, quality and user experience while maintaining regulatory compliance.
- Across functions and organizational boundaries, you will lead initiatives and strategic vendor engagements, provide functional guidance at the intersection of pharmacovigilance and technology, and represent your area in strategic discussions and regulatory inspections.
Unsere Erwartungen an dich
Ausbildung
- Master's degree in computer science or a related field, or equivalent professional qualifications and relevant experience.
Qualifikationen
- Broad knowledge of Good Pharmacovigilance Practice, Patient Safety processes and international pharmacovigilance regulations and guidelines.
- Strong ownership, decision-making and problem-solving skills, with a hands-on mindset and the ability to manage competing priorities and move confidently between strategic and operational topics.
- Excellent communication and collaboration skills, including confidence in working with system vendors and senior stakeholders and representing your area in strategic discussions and regulatory inspections; fluency in written and spoken English.
Erfahrung
- Several years of relevant professional experience in the pharmaceutical industry, a regulatory authority or academia, combined with strong subject-matter expertise.
- Strong experience with cloud-based enterprise systems, process mapping, data flows and computer-system lifecycle processes, ideally within regulated or GxP environments.
- Sound knowledge of Scrum and agile ways of working, combined with project and change management experience and an understanding of database concepts and emerging technologies such as AI.
Unser Angebot
- As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process.
- We also offer a comprehensive benefits and wellbeing package.
- Applications from persons with severe disabilities are warmly welcomed.
- In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.
Benefits
Gesundheit, Fitness & Fun
Themen, mit denen du dich im Job beschäftigst
Job-Standorte
Das ist dein Arbeitgeber
Boehringer Ingelheim ist ein Pharmaunternehmen, das sich seit mehr als 130 Jahren der Erforschung, Entwicklung und Produktion von Medikamenten mit hohem therapeutischen Nutzen für Menschen und Tiere widmet. Als Familienunternehmen planen wir langfristig und investieren daher besonders in die Forschung und Entwicklung. So können wir uns einigen der größten Gesundheitsprobleme unserer Zeit widmen. Unsere Vision „Werte schaffen durch Innovation“ hat unsere Zusammenarbeit seit jeher geprägt und ist sowohl für uns Anspruch als auch Antrieb.
- 1885
- Etablierte Firma
- Onsite, Hybrid
- Pharma, Chemie, Biotech
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