Manager Safety Data Analyst

Beschreibung

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 Zusammenfassung In dieser Position analysierst du komplexe Sicherheitsdaten, unterstützt in Entscheidungsprozessen für regulatorische Einreichungen und optimierst die Analytics-Plattform zur Verbesserung der Arzneimittelsicherheit. 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 ⏰ Flexible Arbeitszeiten 🏠 Home Office 🍼 Kinderbetreuung Mehr Netto 🚎 Verkehrsmittel-Zuschuss 👴🏻 Betr. Altersvorsorge Themen mit denen du dich im Job beschäftigst AI Data Economy Metadaten Level: Erfahren Job Feld: Data Anstellung: Vollzeit Vertragsart: Unbefristetes Dienstverhältnis Arbeitsmodell: Onsite Unternehmenstyp: Etablierte Firma Branche: Pharma, Chemie, Biotech Ort: Mainz | Deutschland

Tech Stack