Senior Safety Scientist in Welwyn

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

We deliver knowledge on the safety profiles of our medicines, define how to manage risks to patients and coordinate the pharmacovigilance system activities for the company providing a safe journey for each individual patient, everywhere.

The Opportunity:

• Contribute to shaping the future of healthcare by providing essential safety science and pharmacovigilance support across the entire Roche portfolio, influencing both early and late-phase development activities.
• Serve as a key member of the safety team, offering crucial 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, encompassing ICSR case management and critical aggregate reporting activities like 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.
• Act independently with minimal supervision, demonstrating strong self leadership, and proactively identifying and pursuing areas for personal and professional development.

Who you are:

Preferred Qualifications:

• A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post graduate health professional qualifications) would be advantageous.
• Demonstrate a strong understanding of GxP, regulated processes, and the end to end clinical trial lifecycle.
• Exhibit excellent communication skills, both written and verbal, capable of effectively collaborating 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.
• Possess strong presentation skills, effective at summarizing and presenting key considerations and decision points to diverse audiences.
• Proven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting safety science activities.

Please note the role level will be determined based on experience and demonstrated expertise. This role is based onsite at our Welwyn, United Kingdom office. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week.

At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. 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 recognise the importance of flexible working and will review all applicants' requests with care.

About Us: We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.