(Senior) Specialist PV Systems & DA

Boehringer Ingelheim; Ingelheim am Rhein; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim in Ingelheim am Rhein seeks a Specialist PV Systems and Data Analysis to ensure PV systems comply with SOPs and global authority requirements. You will support administration, validation, and data retrieval, delivering reliable audits and reports while providing strong user support.

As a Senior Specialist, you may act as SME, lead PV system change controls, train users, and chair the Change Advisory Board, driving improvements across global PV processes and dashboards.

Qualifikationen

• Bachelor’s degree or apprenticeship with long-term experience in biology/statistics/IS-IT.
• Experience with GxP systems and PV software.
• Regulatory/quality compliance knowledge.

Aufgaben

• Support PV systems administration, validation, and data retrieval.
• Assist in change control processes and ensure regulatory compliance.
• Guide global PV users and provide efficient data access.
• Resolve Level 1 system issues and monitor automated processes.
• Senior role: act as SME and lead change controls and trainings.

Kenntnisse

GxP systems

PV systems administration

data analysis

customer service

English fluency

Ausbildung

Bachelor's in biology/statistics/IS-IT

Advanced degree preferred (MSc/MBA)

Tools

PVWorks

GoTrack

Dataland

Dashboards

Jobbeschreibung

The Position

As a Specialist PV (Pharmacovigilance) Systems and Data Analysis, you will play a key role in executing activities that ensure compliance with Boehringer Ingelheim’s PV SOPs and global health authority regulations. You will develop expertise in PV system administration, validation, and data retrieval to support audits and reporting processes. With a strong focus on customer service, you will provide exceptional support to our user community and stakeholders.

As a Senior Specialist, you will additionally be leveraging your expertise as a subject matter expert and also manage projects under the guidance of the Principal Specialist or PV Systems and Data Analytics Associate Director.

This position can be filled either as Specialist PV Systems and Data Analysis or Senior Specialist PV Systems and Data Analysis.

Tasks & responsibilities

• As part of your role, you will actively support PV systems and contribute to change control processes, ensuring smooth operations and continuous improvement
• You will provide assistance in the administration of PV systems across all environments, including development, validation, production, and training
• Moreover, you will guide and support global PV users, helping them navigate system functionalities and fulfill their data retrieval needs efficiently
• Your responsibilities will include ensuring that the system remains compliant with corporate procedures and meets the requirements of various regulatory authorities
• You will take ownership of investigating and resolving Level 1 system issues, ensuring timely and effective solutions
• Additionally, you will execute routine tasks, such as monitoring automated processes, to maintain system reliability and performance

Additional tasks for Senior Specialist PV Systems and Data Analysis

• As Senior Specialist PV Systems and Data Analysis, you will act as a Subject Matter Expert for PV systems, providing expertise and guidance
• You will take the lead in implementing PV systems change controls and driving improvements
• As part of your responsibilities, you will guide and train users, empowering them to utilize the system and retrieve the data they need
• You will also lead the Change Advisory Board, coordinating and overseeing change management activities
• Additionally, you will be responsible for investigating and resolving Level 2 system issues, ensuring solutions to maintain system reliability

Requirements

• Bachelor’s degree in biology, statistics or IS/IT or apprenticeship with additional education or comparable long-term experience
• Few years of experience working with GxP systems with a focus on system support
• Pharmacovigilance Knowledge
• Experience working with PVWorks, GoTrack, or similar validated databases
• Regulatory and / or Quality Compliance experience
• Proficiency with Microsoft office products, specifically advanced graphing in Excel
• Fluent in spoken and written English

Additional requirements for Senior Specialist PV Systems and Data Analysis

• Bachelor’s degree in biology, statistics or IS/IT or apprenticeship with additional education or comparable long-term experience, advanced degree preferred (e.g.: MSc, MBA)
• Several years of experience working with GxP systems with a focus on data analysis
• Experience with Dataland and Dashboards

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.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: [phone] or via mail: [e-mail]

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com