Associate Safety Director/Senior Safety Scientist

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.

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.

The Opportunity:

• 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.

Who you are:

• 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.

Please note the role level will be determined based on experience and demonstrated expertise.

This is the role requiring onsite present at our Basel, Switzerland officeas 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.

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

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.

Roche is an Equal Opportunity Employer.