Senior Safety Scientist / Associate Director / Director

Responsibilities

• Provide essential safety science and pharmacovigilance support across the entire Roche portfolio, influencing early and late-phase development activities.
• Serve as a key member of the safety team, offering 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.
• Take ownership of individual and aggregate case reporting, including ICSR case management and aggregate reporting 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 provide vital drug safety input into the overarching Clinical Development strategy.
• Contribute significantly to risk management by preparing and maintaining CCDS, labeling documents (including the IB), risk communications, RMP, and REMS.

Qualifications

• Relevant postgraduate qualification (e.g., PhD/MSc in a life sciences discipline, medical qualification, PharmD, or other post‑graduate health professional qualification).
• Strong understanding of GxP, regulated processes, and the end‑to‑end clinical trial lifecycle.
• Excellent written and verbal communication skills, able to collaborate effectively with remote partners on a global team.
• Adept at applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarity.
• Strong presentation skills, able to summarize key considerations and decision points for diverse audiences.
• Proven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting safety science activities.

Location

Welwyn, United Kingdom – onsite with a hybrid work structure that requires a fixed number of onsite days per week.

Equal Opportunity Statement

All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognize the importance of flexible working and will review all applicants’ requests with care.

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