PSPV Principal Study Coordinator

The Position

Step into a key role at Boehringer Ingelheim as our next Principal Study Coordinator. Drive the integration of patient safety across clinical studies, streamline data processes, and enhance collaboration within our clinical and post-marketing teams. Utilize your technical skills to support and improve pharmacovigilance operations and cross functional processes. If you're passionate about advancing healthcare from within, we want you. Join us in shaping the future of patient care.

This position can be filled in different countries.
If you want to apply for the position in the USA, please use this link: Principal Pharmacovigilance Safety Study Coordinator Job Details | BoehringerPRD
If you want to apply for the position in Germany click "Apply now".

Tasks & responsibilities

• You will work as part of a team of specialists and independently supporting various Boehringer functions with the pharmacovigilance (PV) related setup activities of clinical studies, ensuring safety and compliance.
• By participating in cross-functional working groups, you will develop user requirements for BDS and PSPV systems and strategize solutions for efficient safety processes in clinical studies.
• Engaging in critical discussions with PSPV, Clinical Operations, Biostatistics, and Data Science is a key responsibility to ensure patient safety considerations are embedded in trial protocols.
• Collaborating with outsourcing vendors will be part of your role to align safety management plans with trial execution.
• Adopt technologies and design and implementing tools will fall under your purview to optimize operational processes.
• Performing a variety of PV operational tasks, from protocol review, ICSR quality review, reconciliation to setup of data distributions, will be essential to maintain the quality and integrity of global case management.

Requirements

• Master’s degree in pharmacy, health care/life science related fields, medical information science/data science, or equivalent job experience, complemented by a few years of experience in the pharmaceutical industry, ideally within pharmacovigilance and clinical research environments.
• Demonstrated analytical and programming capabilities, with at least an intermediate proficiency in, R, or Python, or equivalent programming skills (e.g. JAVA, HTML, VBA, DAX etc.)  and a solid understanding of relational databases, emphasizing the need for basic IT skills.
• Solid familiarity of international regulatory requirements related to Pharmacovigilance and clinical study activities, with a strong affinity for working in a highly regulated environment, ensuring meticulous and precise work to maintain regulatory compliance.
• Independent problem-solving skills and decision-making ability, coupled with a high independent work ethic and the capacity to prioritize tasks effectively under pressure.
• Solid background in Clinical Development, including Pharmacovigilance operations, Clinical Operation, Biometrics, and Data Management, demonstrating a comprehensive understanding of the clinical trial process and the ability to ensure company compliance with respect to regulatory reporting of safety information.
• Excellent communication skills in English and proficiency in electronic data capture tools and Microsoft Office Suite, with an affinity for quickly adapting to new technologies such as Microsoft Teams, SharePoint, and Microsoft Power Tools.

Ready to contact us? 

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process: 
Step 1: Online application - The job posting is presumably online until June 25th, 2025. 
Step 2: Virtual meeting in the period from the middle of June until the beginning of July 2025.