Associate Director Safety Data Analyst

As the Associate Director Safety Data Analyst, you will play a pivotal role within the Medical Safety and Pharmacovigilance department at BioNTech, serving as the primary contact for Safety Strategy Leads, Safety Physicians, and Safety Scientists. 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, the Associate Director is responsible for 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, the Associate Director ensures the platform evolves by delivering innovative data solutions that enhance medical safety and pharmacovigilance data assessments.

Main Responsibilities:

• Act as the primary contact for Safety Strategy Leads, Safety Physicians, and Safety Scientists, delivering strategic safety data analysis. 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.
• Implement, validate, and continuously improve 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.
• Drive 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.

Do you have a Master's degree?, * Master's degree in life sciences, computational sciences, data sciences, or related fields (doctorate preferred).

• Multiple years of experience in pharmaceutical/biotech data analysis and the pharmaceutical industry.
• Strong knowledge of pharmacovigilance regulations (GCP, GVP) and FDA, EMA, and 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.

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!