Medical Safety Specialist

India

About the role

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!
Job Purpose:
Provide support to the Medical Safety Experts (MSE)/Medical Safety Leads (MSL)/Global Program Safety Lead (GPSLs)/ Group Head, Medical Safety Operations/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA according to the needs for delivery activities, i.e. co-authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Provide support to the GPSLs by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with Patient Safety business rules, standard operating procedures and global and local regulatory requirements.
Your Key Responsibilities:
-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.