As the Manager, Safety Data Analyst, you will play a key role within the Medical Safety and Pharmacovigilance department at BioNTech. Your expertise in strategic data analysis will transform complex datasets into actionable insights, driving informed decision-making for regulatory submissions and shaping the safety profiles of BioNTech’s innovative product portfolio.
In addition to supporting safety teams with strategic safety data analysis, you will support the implementation and continuous improvement of BioNTech's in-house analytics platform within a cross-functional setting. This platform enables safety teams to efficiently perform signal management and benefit-risk management activities. Furthermore, you will ensure the platform evolves by delivering innovative data solutions that enhance medical safety and pharmacovigilance data assessments.
Prepare and present actionable insights from complex datasets to enable efficient, data-driven decision-making for signal management, benefit-risk assessments, and medical scientific/pharmacovigilance evaluations
Support the implementation, validation, and continuous improvement of BioNTech’s in-house safety analytics platform, ensuring reliability, data integrity, and compliance with regulatory and organizational standards
Support the creation and maintenance of comprehensive safety data catalogues to ensure organized, accessible, and well-governed safety data management practices
Support initiatives for data automation, leverage artificial intelligence, and deliver innovative solutions to enhance safety analytics processes, improving efficiency and accuracy
Ensure all safety data analytics activities align with FDA, EMA, GCP, GVP, and ICH regulatory standards
Master’s degree in life sciences, computational sciences, data sciences or related fields (doctorate preferred)
Relevant experience in pharmaceutical/biotech data analysis or related areas within the pharmaceutical industry
Proven expertise in conducting medical safety and pharmacovigilance data assessments within validated computer systems
Proficiency in SQL and Python or R; Excellent English communication skills to engage stakeholders and translate data insights into actionable recommendations
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Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
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Munich, Germany location by sending us your documents via our online form.