Medical Safety Expert

Your Key Responsibilities

• Your responsibilities include, but not limited to:
• 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 documents, as well as ad hoc Health Authority queries.
• 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.
• Support maintenance and management of local deviations -Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input).
• Prepare responses to internal safety requests and contribution to responses to external safety queries.
• Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues -Distribution of marketing samples (where applicable)

What you’ll bring to the role:

Why Sandoz?