Senior Medical Safety Expert (Hyderabad)

Senior Medical Safety Expert (Hyderabad)

- 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 recent 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

📌 Senior Medical Safety Expert
🏢 Novartis
📍 Hyderabad

The original job offer can be found in Kit Job:
kitjob.in/job/179147782