NOVARTIS Medical Safety Expert Bachelor of
Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant
field or Medical Degree (MBBS or MD) required
Job Description
1. 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.
2.
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.
3. Perform Literature review for PSUR
inclusion and assessment of literature for ICSRs.
4. Provide support for the preparation of
ad hoc Health Authority queries for TAs, also in particular for short term
notice requests.
5. 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.
6. 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).
7. 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). 5 Perform Empirica outputs review and signal tracking in SMART. 6
Provide safety input (Addendum to Clinical Overview) for license renewal documents.
7 Provide support as needed for new
indication submission (regulatory document safety input).
8 Co-author medical assessment of product
quality issues. 9 Assist in the preparation of Product Guidance Documents
(PGDs) for marketed products. 10 Contribute to the development and update of
RMPs in collaboration with Safety Heads, coordination with other functions, and
tracking.
11 Prepare responses to internal safety
requests and contribution to responses to external safety queries.
12 Act as Subject Matter Expert (SME) for
Medical Operations/ Medical Function (participation in initiatives).
13 Lead the training and mentoring of
junior Medical Safety Experts.
Minimum requirements
Bachelor of Science in Pharmacy /Bachelor
of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or
MD) required. Good knowledge/fluency in English. Knowledge of other languages
desirable.
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