Senior Safety Scientist - PV & Risk Lead (Hybrid, UK)

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 65,000 - 90,000; Full time

Job summary

Roche Welwyn, United Kingdom, is seeking a safety science and pharmacovigilance specialist to provide essential safety oversight across the portfolio, influencing study management from development through post-market.

Based onsite at Welwyn with a hybrid structure, you will lead post-market safety activities, manage ICSR and aggregate reporting, and contribute to risk management documents such as CCDS, labeling, RMP, and REMS, while collaborating with a global remote team.

Qualifications

• Postgraduate qualification (e.g. PhD/MSc in Life sciences or related health field) advantageous.
• Strong understanding of GxP, regulated processes, and end-to-end clinical trial lifecycle.
• Excellent written and verbal communication; able to collaborate with remote partners globally.
• Able to apply complex data analysis and statistics to interpret data.
• Strong presentation skills to summarize decisions to diverse audiences.
• Proven ability to work independently and manage safety responsibilities.

Responsibilities

• Lead post-market safety activities including signal evaluation and risk management.
• Take ownership of case reporting (ICSR) and DSUR/PBRER reporting.
• Provide input into Clinical Development strategy and safety assessments.
• Prepare CCDS, labeling documents, risk communications, RMP, and REMS.

Skills

GxP knowledge

Regulated processes

Clinical trial lifecycle

Data analysis

Statistics

Presentation skills

Independent work

Communication skills

Education

Postgraduate qualification (PhD/MSc life sciences; medical qualification; PharmD)

Job description

Roche Welwyn, United Kingdom, is seeking a safety science and pharmacovigilance specialist to provide essential safety oversight across the portfolio, influencing study management from development through post-market.

Based onsite at Welwyn with a hybrid structure, you will lead post-market safety activities, manage ICSR and aggregate reporting, and contribute to risk management documents such as CCDS, labeling, RMP, and REMS, while collaborating with a global remote team.