Associate Safety Director/Senior Safety Scientist

Roche seeks a Senior Safety Scientist in Basel to oversee pharmacovigilance, manage risk assessments, and support clinical development across its global portfolio.

This position serves as a central figure in Roche’s safety organization, providing expert oversight for medicines from early development through post-market phases. The role ensures robust risk management for patients while coordinating pharmacovigilance activities and influencing clinical strategies across the entire product portfolio.

Responsibilities

• Provide essential safety oversight and strategic input for study management throughout the product lifecycle, from initial development to post-market surveillance.
• Lead post-market safety initiatives, including the evaluation of safety signals, benefit-risk assessments, and the implementation of comprehensive risk management plans.
• Manage individual case safety reports (ICSRs) and oversee critical aggregate reporting duties, such as the preparation of Development Safety Update Reports (DSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER).
• Drive the detection and management of safety signals, contributing to the strategic review of safety assessments and drug safety documentation.
• Shape product safety strategies and integrate vital safety perspectives into the broader Clinical Development framework.
• Support risk management efforts by preparing and maintaining key documents, including the Core Clinical Data Summary (CCDS), Investigator Brochures (IB), risk communications, Risk Management Plans (RMP), and Risk Evaluation and Mitigation Strategies (REMS).

Requirements

• Demonstrate a thorough understanding of Good Practice (GxP) regulations, regulated processes, and the full clinical trial lifecycle.
• Showcase excellent written and verbal communication skills, with the ability to collaborate effectively with global, remote partners.
• Apply complex data analysis and statistical methods to evaluate, interpret, and present scientific findings clearly.
• Possess strong presentation abilities, capable of summarizing key considerations and decision points for diverse audiences.
• Work independently with minimal supervision, managing safety responsibilities on study teams and supporting clinical safety activities.

Nice to have

• A postgraduate qualification such as a PhD or MSc in a Life Sciences discipline.
• A medical qualification, PharmD, or other postgraduate health professional credentials.

About the company

Roche is a global health company with more than 100,000 employees dedicated to advancing science to deliver life-changing healthcare solutions. The organization’s mission is to prevent, stop, and cure diseases while ensuring everyone has access to healthcare today and for generations to come. The culture encourages personal expression, open dialogue, and genuine connections, where employees are valued, accepted, and respected.

• A workplace that values personal expression, open dialogue, and genuine connections.
• A mission-driven environment focused on preventing, stopping, and curing diseases.
• A global community of over 100,000 employees dedicated to advancing science for healthcare access.