Summary
About the Role
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 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)
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.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
