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Medical Safety Expert

1 month ago

Telangana, India Sandoz Full time

**Major accountabilities**:

- Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Assist the GPSL/MSL/MSE in monitoring the safety profile of products including with activities such as literature review, medical assessment, and related activities for single cases, including collecting additional follow-up information as necessary.
- Support Literature review for PSUR inclusion and assessment of literature for signals. Together with the Safety Leads, co-author the PSUR sections as required.
- Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA. Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Risk Management Plan (RMP), Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).
- Support the safety lead with medical assessment of product quality issues (e.g. - Filling out relevant sections of the MRA). Support in preparation of responses to internal safety requests and contribute to responses to external safety queries. Writing of meeting minutes.
- Updating the Medical Safety SharePoint, uploading of documents, tracking, and planning list updates. Support the safety lead as required for the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels. Provides support as needed for regulatory authority inspections and internal/external audits. Assist in Root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) as appropriate.
- Support writing of working instructions and procedures. Preparing presentations with support from the safety lead as applicable for various safety teams as well as leadership forums. Support the MSL/GPSL in their assigned projects and deliverables.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Join us

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Sandoz

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