Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
