Position Overview
Deliver knowledge on safety profiles of medicines, define risk management, and coordinate pharmacovigilance system activities to provide a safe journey for each patient worldwide.
Key Responsibilities
- Contribute to shaping the future of healthcare by providing essential safety science and pharmacovigilance support across the Roche portfolio, influencing 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 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.
- Act independently with minimal supervision, demonstrating strong self‑leadership and proactively identifying and pursuing areas for personal and professional development.
Qualifications
- A relevant postgraduate qualification (e.g., PhD/MSc in a Life Sciences discipline; medical qualification; PharmD or other post‑graduate health professional qualification) would be advantageous.
- Strong understanding of GxP, regulated processes, and the end‑to‑end clinical trial lifecycle.
- Excellent communication skills, both written and verbal, capable of effectively collaborating with remote partners on a global team.
- Proficient in applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarity.
- 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.
Location
This role is based onsite at our Welwyn, United Kingdom office. The team follows a hybrid work structure, requiring 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. 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.
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