Manager, Safety Data Analyst
BioNTech SE
full-time
Posted on:
Location Type: Hybrid
Location: Mainz • Germany
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Tech Stack
About the role
- 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
Requirements
- 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
- Strong knowledge of pharmacovigilance regulations (GCP/GVP) as well as FDA/EMA/ICH guidelines
- Proven expertise in conducting medical safety and pharmacovigilance data assessments within validated computer systems
- Proficiency in SQL and Python or R; experience with visualization tools as well as familiarity with cloud computing platforms
- Excellent English communication skills to engage stakeholders and translate data insights into actionable recommendations
- Experience with Databricks and Spotfire is a plus
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data analysispharmacovigilanceSQLPythonRdata automationartificial intelligencedata integritymedical safety assessmentssafety data management
Soft Skills
communicationstakeholder engagementactionable insightsdecision-makingorganizational skillsproblem-solvinginnovationcollaborationpresentation skillstranslating data insights