Group Director - Safety Analytics and Reporting(m/w/x)

Beschreibung

You will lead the company's safety data science and pharmacoepidemiology efforts, ensuring high-quality evidence generation and GxP compliance to optimize the benefit-risk profile of medicines.

Anforderungen

• •Advanced degree in Data Science, Quantitative/Natural Sciences, or qualified health professional
• •10+ years experience in PV/safety, clinical data, or pharmacoepidemiological analysis
• •5+ years of people leadership experience
• •Track record of delivering evidence in GxP environments
• •5+ years experience with drug safety databases
• •Expert-level knowledge of drug development lifecycle
• •Hands-on mastery of statistical analysis and medical data reporting
• •Strategic understanding of AI-based approaches like LLMs and Neural Networks
• •Advanced analytical thinking and communication skills
• •Ability to synthesize complex information and influence collaborations
• •Highly developed communication and influencing skills
• •Comprehensive knowledge of data structures and business processes
• •Fluency in English and ideally German

Aufgaben

• •Provide strategic leadership for the global SAR sub-function
• •Coach team members to maximize potential and well-being
• •Direct safety analytics, data science, and pharmacoepidemiology vision
• •Ensure consistent evidence generation for PDS obligations
• •Manage 24/7 database access and search execution
• •Oversee timely DSURs, PBRERs, and signal detection reporting
• •Maintain inspection readiness and timely CAPA responses
• •Provide expert guidance on AI and statistical methods
• •Equip the SDS team with data and analytics tools
• •Lead the strategy for Real World Data and Evidence
• •Manage global recruitment, onboarding, and resource deployment
• •Partner with stakeholders to anticipate future opportunities
• •Contribute to scenario planning and budget management

Tools & Technologien