Senior Safety Scientist / Associate Director / Director

About the role

Roche is looking for a Senior Safety Scientist, Associate Director or Director to join its safety team in Welwyn, United Kingdom. The role delivers knowledge on the safety profiles of medicines, defines how to manage risks to patients and coordinates pharmacovigilance system activities across the entire Roche portfolio, from early and late-phase development through post-market. The position is onsite at the Welwyn office within a hybrid work structure.

Key responsibilities

• Serve as a key member of the safety team, giving safety oversight and input into all aspects of study management from development through post-market.
• Lead critical post-market safety activities, including signal evaluation, benefit-risk assessment and comprehensive safety risk management.
• Own individual and aggregate case reporting, including ICSR case management and critical aggregate reports such as DSUR and PBRER.
• Drive signal detection and management, and contribute to the strategic review of safety assessments and drug safety reports.
• Influence product safety strategy and give drug safety input into the overall Clinical Development strategy.
• Prepare and maintain CCDS, labeling documents (including the IB), risk communications, RMP and REMS, and contribute to risk management.

Required profile

• A relevant postgraduate qualification (e.g. PhD/MSc in a life sciences discipline, medical qualification, PharmD or other post-graduate health professional qualification) is advantageous.
• Proven ability to act independently with minimal supervision, managing safety responsibilities on study teams and supporting safety science activities.
• Strong self-leadership and proactive identification of areas for personal and professional development.

Required skills

• Strong understanding of GxP, regulated processes and the end-to-end clinical trial lifecycle.
• Excellent written and verbal communication, able to collaborate with remote partners on a global team.
• Ability to apply complex data analysis and statistical methods to evaluate, interpret and present scientific data clearly.
• Strong presentation skills, able to summarise key considerations and decision points for diverse audiences.