Medical Safety Expert, Sandoz

About the role

-Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations.

What you'll do

• Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical…
• Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection
• Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests
• Perform follow up activities on Health Authority Assessment Reports
• Assist in providing safety input to Regulatory Affairs and clinical documents

What you need

• Clinical research
• Regulatory affairs