(Senior) Specialist PV Systems & DA

Boehringer Ingelheim GmbH; Waldstetten; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Benefits and wellbeing package

Salary transparency during recruitment

Zusammenfassung

Boehringer Ingelheim GmbH seeks a Specialist or Senior Specialist PV Systems and Data Analysis to ensure PV system compliance and data integrity. You will support system administration, change control, and user guidance to meet regulatory requirements.

The role includes potential leadership in change management and training, with a focus on delivering reliable PV data for audits and reporting.

Qualifikationen

• Bachelor-level education in biology, statistics or IS/IT, or equivalent experience.
• Experience with PV systems and validated databases (PVWorks/GoTrack).
• Fluent English written and spoken.

Aufgaben

• Support PV systems administration and change control processes.
• Assist in system administration across development, validation, production, and training environments.
• Support global PV users and ensure data retrieval needs are met.

Kenntnisse

PV systems knowledge

GxP systems experience

English fluency

Ausbildung

Bachelor’s degree in biology, statistics or IS/IT

Advanced degree preferred (MSc, MBA)

Tools

PVWorks

GoTrack

Jobbeschreibung

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.

The job posting is presumably online until 25 September.

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]