Major Accountabilities:
- Provide support for delivery activities, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Perform medical review of ICSRs, including SUSARs, cases from special countries, and assessment of literature cases; author enhanced MAC.
- Support the safety lead in authoring medical assessment letters based on bi-annual/six-monthly line listings.
- Perform literature review of assigned articles (CQC, pre-screening, and SICO) and assist the safety lead in reviewing articles for inclusion in PBRER, DSUR, IB, etc.
- Provide rotating support to the TAs as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents.
- Assist TA Safety Leads in monitoring the safety profile of products, including literature review, medical review of individual cases, collecting additional follow-up information, and medical evaluation of quality defects.
- Co-author the PBRER with Safety Leads, providing medical inputs to sections 9, 15, 16, 17, and 18, and analytical input for risks defined in the RMP. Perform follow-up activities on HA assessment reports.
- Contribute to the medical sections of Development Safety Update Report (DSUR), Investigator Brochures (IB), labeling documents (e.g., CDS, SMPC, USPI, Japanese PI), Product Guidance Documents (PGD), and Expert Statements.
- Support the preparation and review of Investigator Notifications (INs), signal detection, and signal evaluation activities for assigned products.
- Assist in evaluating and writing safety-related documents, including Clinical Overview, Development Safety Profiling Plan (d-SPP), and RMP.
- Provide safety input to Addendum to Clinical Overview (ACO) for license renewal and new indication submission.
- Support the preparation and participation in internal review meetings like SMT, MSRB, and GLC.
- Act as Subject Matter Expert (SME) for Medical Function processes and provide support during audits and inspections.
- Collaborate with other Global Line Functions across Novartis and third parties to meet joint accountabilities.
- Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality.
- Develop and optimize training materials and deliver training to Novartis staff and external stakeholders.
