Sandoz is a global leader in generic and biosimilar medicines, which are more affordable versions of brand-name drugs. The Swiss-based company was part of Novartis until October 2023 when it became an independent entity, and its products reach millions of patients worldwide. Sandoz also provides active pharmaceutical ingredients and has a portfolio of approximately 1,300 products, including over-the-counter medications and treatments for a wide range of conditions from cancer to the common cold.
Post : Medical Safety Expert
Job Description
• 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)
Essential Requirements
• People Challenges.
• Managing Crises.
• 8+ years of relevant experience
• 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.
Additional Information
Experience : 8+ years
Location : Telangana (Sandoz)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
Job ID : REQ-10031606
End Date : 20th October 2026
Medical Safety Expert : Apply Online
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