Senior CSSD Scientist
Senior CSSD Scientist
Switzerland, Basel-Town, Basel
The Sr. CSSD Scientist supports early and late phase development activities as a member of the safety team under the leadership of the SSL providing essential safety oversight and input into all aspects of study management across the entire development portfolio. In the post-market setting, this role contributes to safety science deliverables required to maintain license to operate and to manage and communicate the evolving safety profile.
- Represent Safety Science with business process owners on processes executed by Safety Science
- Responsible for coordination and collaboration with vendors servicing Safety Science
- Trains and mentors more junior members of the safety team
In collaboration with the SSL:
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
- Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports.
- Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
We are looking for a professional with Bachelor’s degree in healthcare related field or equivalent experience and 3
years of relevant experience. You will bring:
- Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area
- Understanding of GxP and regulated processes and end to end clinical trial lifecycle
- Strong orientation towards process improvement and cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent communication skills, both written and verbal
- Perform application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
- (For roles in China) Fluent in Mandarin and English
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more
Roche is an equal opportunity employer.
- Location Switzerland, Basel-Town, Basel
- Function Development
- Subfunction Drug Safety
- Schedule Full-time
- Job level Individual Contributor
- Job type Regular Employee
- Division Roche Pharmaceuticals
- Posted since 2017/12/12
- Job-ID 2778323240