Job vor 6 Tagen bei Jobvector gefunden
BioNTech SE
Biologist as Associate Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
Jobticket
Associate
Director Clinical Safety Management (m/w/d) Mainz, Germany; London, United Kingdom; Munich, Germany full time Job ID:9007As Associate Director Clinical Safety Management, you will provide scientific and strategic expertise to our clinical
development programs. Core responsibilities include safety data review, periodic report preparation, and global safety database oversight. Provide expert scientific input to clinical safety activities, including safety database analysis, authoring and reviewing study-related documents (e. g. , Safety Management Plans, Reconciliation Plans, structured Benefit-Risk Assessments) , and leading the preparation
of periodic safety reports (e. g. , DSURs) in collaboration with cross-functional teams. Partner with safety physicians to review and contribute to safety-relevant sections of clinical trial protocols, investigator brochures, clinical study reports, and statistical outputs (tables, figures, listings) , and to co-author relevant safety documentation for BioNTech compounds. Actively lead or contribute to BioNTechs Safety Surveillance Teams (SST) and Safety Management Teams (SMT) , including meetings to ensure consistent safety oversight, data provision, and decision-making for assigned compounds. Drive the development, implementation, and continuous improvement of safety database processes. Oversee and enhance strategies and business processes including system configuration, vendor collaboration, and alignment of internal safety processes. Serve as primary scientific point of contact for clinical safety team members including [...] regulations, and ethical requirements, and act as a Subject Matter Expert during audits and inspections for core safety processes. Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred) Minimum 5 years of experience in clinical
research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry, including case processing activities Strong knowledge of applicable regulatory, GCP, and GVP requirements in key geographies Experience overseeing safety database functionality and configuration, including coordination with internal stakeholders and external vendors Strong computer proficiency, including experience with safety database set-up and data visualization tools Fluent in written and spoken English Your flexibility: flexible hours vacation account Your growth: Digital Learning Performance talent development leadership development Apprenticeships Linked In 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 43408416 [...]
Alle Biologist Stellenangebote anzeigen