Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Medical Safety Expert
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). 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).
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.
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / Pharm.D / PhD in relevant field or Medical Degree (MBBS or MD) required. Good knowledge/fluency in English. Knowledge of other languages desirable.
• May be a first job in the pharmaceutical industry for an MD with 3 or more years of clinical experience after graduating from medical school
• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
• Excellent understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused
• Strong organizational and project management skills
• Strong negotiation and communication skills, and the ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Strong technical and problem solving skills
• Good presentation skills
• Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
• Ability to work independently, under pressure, demonstrati
Experience : 3+ years
Qualification : B.Pharm, Pharm.D/PhD
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Safety
End Date : 20th February, 2020
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