Associate Safety Director​/Senior Safety Scientist Welwyn

The Position

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.

• Contribute to shaping the future of healthcare by providing essential clinical safety 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, contribute to the strategic review of safety assessments and drug safety reports.
• Influence product safety strategy and provide vital 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 post graduate qualification 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 clinical safety activities.

This role requires onsite presence at our Basel, Switzerland office as the primary location. Our team follows a hybrid working model with a defined number of onsite days per week. Welwyn may also be considered as a secondary location for this job.

Roche is an Equal Opportunity Employer.