Major Accountabilities
• 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 current 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) Key Performance Indicators
• Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements Work

Experience:
• People Challenges.
• Managing Crises.
• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management. Skills
• Clinical Research.
• Clinical Trials.
• Functional Teams.
• Literature Review.
• Medical Records.
• Process Safety.
• Regulatory Compliance.
• Safety Science.
• Languages :
• English.

📌 Medical Safety Expert, Sandoz (India)
🏢 Sandoz India
📍 India