(Senior) Specialist PV Systems & DA

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. 

If you are ready to take on this impactful role, we look forward to receiving your application!

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