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 contributing 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.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.
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.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. 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. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
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