Job
- Level
- Erfahren
- Job Feld
- Data
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
- Ort
- Mainz
- Arbeitsmodell
- Onsite
Job Zusammenfassung
In dieser Position analysierst du komplexe Sicherheitsdaten, unterstützt in Entscheidungsprozessen für regulatorische Einreichungen und optimierst die Analytics-Plattform zur Verbesserung der Arzneimittelsicherheit.
Job Technologien
Deine Rolle im Team
- 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.
Unsere Erwartungen an dich
Ausbildung
- Master's degree in life sciences, computational sciences, data sciences or related fields (doctorate preferred).
Qualifikationen
- 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.
- Excellent English communication skills to engage stakeholders and translate data insights into actionable recommendations.
Erfahrung
- Relevant experience in pharmaceutical/biotech data analysis or related areas within the pharmaceutical industry.
- Proficiency in SQL and Python or R; experience with visualization tools as well as familiarity with cloud computing platforms.
- Experience with Databricks and Spotfire is a plus.
Unser Angebot
- 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.
Benefits
Work-Life-Integration
Mehr Netto
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
BioNTech AG
BioNTech ist ein Immuntherapie-Unternehmen, das bei der Entwicklung von Therapien für Krebs, Infektionskrankheiten und seltene Erkrankungen Pionierarbeit leistet. Das Unternehmen kombiniert Immunologieforschung, moderne therapeutische Plattformen und Bioinformatik-Tools, um die Entwicklung neuartiger Biopharmazeutika rasch voranzutreiben.
Description
- Unternehmensgröße
- 250+ Employees
- Gründungsjahr
- 2008
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech
Manager Safety Data Analyst
- Ort
- Mainz
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
- Nur Englisch
- Nur Englisch erforderlich
