Group Director Safety Analytics and Reporting

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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 teams 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 Networks.

• You exhibit advanced analytical thinking and highly developed communication skills enabling you to synthesize complex information influence global collaborations and drive decisions amidst ambiguity.

• You utilize highly developed communication and influencing skills to build global collaborations and drive decisions.

• You maintain comprehensive knowledge of data structures and business processes to guide direct reports while being fluent in English (proficiency in German is a plus).

Location & Travel Requirements

• This position must be based in either Basel Switzerland or Welwyn Garden City in the United Kingdom. Although this can be a hybrid role with an expectation of ongoing and sustained site presence in compliance with local company site requirements.

• International business travel may be required. Typically this will be required around 10% of the time depending upon the site location of the jobholder and/or the requirements of the role for ongoing leadership or business project-related activities.

Scientific rigour and creativity inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together we can be transformative.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.