Senior Safety Scientist (m/w/d)

Mainz, Germany; London, United Kingdom; Munich, Germany   |   full time   |   Job ID: 9008 

 

 

As a Senior Safety Scientist (m/w/d), you will provide scientific and strategic expertise to our clinical development programs at a compound level. Core responsibilities include safety data review, periodic report preparation, and oversight of the safety surveillance process.
 

Your main responsibilities are:

 

• Provide expert scientific input to clinical safety activities, including safety database analyses, authoring and reviewing trial-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.
• Drive the development, implementation, and continuous improvement of safety signal processes and oversee and enhance safety surveillance across clinical programs.
• Actively lead or contribute to BioNTech’s Safety Surveillance Teams (SST) and Safety Management Teams (SMT), including organizing and facilitating meetings to ensure consistent safety oversight and decision-making for assigned compounds.
• Serve as primary scientific point of contact for clinical safety team members assigned to clinical trials including best practice approaches, project-specific mentoring and training.
• Support collaboration by providing training and scientific guidance on safety management practices to colleagues in cross-functional departments.
• Build subject matter expertise in focus areas such as data analytics, signal detection, BRA, or literature review, and support regulatory interactions by contributing to authority requests and safety-related communications.
• Manage and update key standard operating procedures (SOPs) related to safety processes, ensure all safety management activities align with BioNTech’s quality standards, global regulations, and ethical requirements, and act as a Subject Matter Expert during audits and inspections for core safety processes.

What you have to offer:

 

• 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 in designing and implementing clinical safety processes, support systems, and tools
• Excellent scientific writing, project management, and cross-functional collaboration skills
• Strong computer proficiency, including experience in data visualization tools
• Fluent in written and spoken English

 

 

Your Benefits:

 

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 

 

 

Apply now - We look forward to your applic