Medical Safety Expert (Pharmacovigilance)

Provide rotating support to the TAs 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 the TA Safety Leads in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. Medical review of single case reports will be performed by associates possessing medical degree. Perform Literature review for PSUR inclusion and assessment of literature for ICSRs. Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. Together with the Safety Leads, co-author the PSUR, in particular provide medical inputs to sections 15, 16, 17, 18, including analytical input to PSUR for known and potential risks defined in the RMP. Perform follow up activities on Health Authority Assessment Reports. Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), Support maintenance and management of local deviations (SMPC, USPI, Japanese PI). Assist in evaluating and writing other safety deliverables including but not limited to clinical overviews, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR). Perform Empirica outputs review and signal tracking in SMART. Provide safety input (Addendum to Clinical Overview) for license renewal documents. Provide support as needed for new indication submission (regulatory document safety input). Co-author medical assessment of product quality issues. Assist in the preparation of Product Guidance Documents (PGDs) for marketed products. Contribute to the development and update of RMPs in collaboration with Safety Heads, coordination with other functions, and tracking.