Job
In this role, you support pharmacovigilance processes, taking functional ownership of Global Safety Platform modules while shaping solution design, implementation, and validation both strategically and operationally.
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Your role in the 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, technological 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.
- Als Teil von Plattformänderungen bewertest du die Auswirkungen und steuerst risikobasierte Validierungen und Tests, einschließlich Testprüfungen, Problemlösungen, Business Readiness und Schulungsbedarf gemäß den Anforderungen von GxP und der Pharmakovigilanz.
- For releases and enhancements, you will ensure business readiness and reliable operations, 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.
Our expectations of you
Education
- Master's degree in computer science or a related field, or equivalent professional qualifications and relevant experience.
Qualifications
- 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.
Experience
- 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 in regulated or GxP environments.
- Sound knowledge of Scrum and agile ways of working, combined with experience in project and change management and an understanding of database concepts and emerging technologies such as AI.
What we offer
- 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
Health, fitness & fun
Topics you will work on
Job locations
About your employer
For over 130 years, Boehringer Ingelheim has been probing, creating and producing novel medications with high therapeutic advantages for people as well as animals. As a family-run pharmaceutical enterprise we plan long-term and consequently invest heavily in research & development. We take great pride in tackling some of the biggest health issues our world faces today. Our vision “Creating Values through Innovation” has always shaped our collaboration while serving both as requirement and momentum at once.
- 1885
- Established Company
- Onsite, Hybrid
- Pharmaceutical Sector, Chemical Industry, Biotech
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