Group Director - Safety Analytics and Reporting

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.### ### The Position At Roche, our Global Product Development Safety & Risk Management (PDS) department aims to enhance healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile.### The Opportunity The Group Director of Safety Analytics and Reporting (SAR) provides strategic leadership, expertise and oversight for safety data science, pharmacoepidemiology, analytical excellence and complex safety information reporting throughout the Roche product lifecycle.

They ensure that high-quality evidence from safety databases, real-world data, and literature is generated accurately and in a timely manner. This role is a vital enabler for GxP compliance and advanced scientific safety research.

As a member of the PVSD Leadership Team, the Group Director leads the global SAR function across Basel, Welwyn, and South San Francisco. This role integrates GxP safety knowledge with advanced safety data science expertise to support process experts across GVP, GCP, and medical devices safety. By partnering with PDS, R&D, and Roche Digital Technology (RDT), the Director drives the evolution of innovative evidence generation and analytical data science.  

The Group Director also ensures safety analysis adheres to global regulations and policies. Ultimately, the team collaborates cross-functionally to provide technical expertise and high-quality safety deliverables throughout the entire Roche asset lifecycle.

The Group Director leverages the strengths of a diverse global team and creates an inspiring environment where the SAR team members feel empowered to take ownership of deliverables, build knowledge and deploy resources effectively, always striving for continuous improvement.

The SAR team's remit spans four main areas:
* * Safety reporting:
* Safety database activities for regulatory deliverables and insights.
* * Safety data science:
* Advanced analytics and modeling on selected safety endpoints, including signal assessment.
* * Pharmacoepidemiology:
* Providing context for clinical/medical safety assessments, patient safety research, and regulatory reporting.
* * Pharmacovigilance Support:
* Complex literature searches for ICSR identification and signal management.

Primary Responsibilities and Accountabilities:
* * Leadership:
* Provides line-leadership for the global SAR sub-function; coaches members to maximize potential and well-being while sustaining a climate of purpose and urgency.
* * Strategic Direction:
* Provides vision for safety analytics, data science, pharmacoepidemiology, and literature analysis. Ensures the team executes consistent evidence generation to meet PDS obligations.
* * Operations & Compliance:
* Ensures 24/7 database access (delegated by EU QPPV) and timely, accurate execution of searches (DSURs, PBRERs, signal detection, audits). Ensures inspection readiness and timely CAPA responses.
* * Technical Expertise:
* Provides SME guidance on analytical/statistical methods and technologies (AI, LLMs, Safety AI frameworks).
* Technical tools:
Ensures that the SDS team has access to relevant data sources and analytics tools to perform comprehensive analysis in support of characterizing risk.
* * Evidence Generation:
* Leads PDS strategy for Real World Data/Evidence (RWD/E) to support the Roche portfolio, collaborating closely with PDD and PDMA.
* * Resource Management:
* Oversees recruitment, onboarding, and deployment of SAR resources across multiple locations based on strategic value.
* * Stakeholder & Strategy:
* Partners and maintains relationships with key stakeholders; anticipates future opportunities via internal/external networks. Contributes to PVSD leadership in scenario planning, prioritization, and budget management.### Who you are
* You hold an advanced degree in Data Science, Quantitative/Natural Sciences, or are a qualified health professional, supported by at least 10+ years of experience in PV/safety, clinical data, or pharmacoepidemiological analysis.
* You possess at least 5 years of people leadership experience and a proven track record of delivering high-quality evidence within highly regulated GxP environments and complex, high-risk projects.
* You offer 5+ years of experience with drug safety databases and expert-level knowledge of the drug development lifecycle, from first-in-human trials to marketed products.
* You demonstrate hands-on mastery of statistical analysis and medical data reporting, complemented by a strategic understanding of AI-based approaches like LLMs and Neural…