Job Description

About The Role Job Purpose Provide support to the Medical Safety Therapeutic Areas 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. Major Activities (Describe main activities) 1. Provide support to a TAs according to the needs for delivery activities, i.e. ICSR medical review 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 GPSLs 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, medical evaluation of quality defects 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, provide input into responses to inquiries from health care professionals on safety issues 5. Together with the Safety Leads, co-author the PSUR sections, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. 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 Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR). 8. Provide safety input (Addendum to Clinical Overview) for license renewal documents. 9. Provide support as needed for new indication submission (regulatory document safety input). 10. Co-author medical assessment of product quality issues. 11. Assist in the preparation of Product Guidance Documents (PGDs) for marketed products. 12. Contribute to the development and update of RMPs in collaboration with PVL/GPSL, coordination with other functions. 13. Prepare responses to internal safety requests and contribute to responses to external safety queries. 14. Act as Subject Matter Expert (SME) for Medical Safety Expert office/Medical Operations/ Medical Function (participation in initiatives). Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements Minimum Requirement Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required. Medical degree is essential for associates performing medical review of single case reports. May be a first job in the pharmaceutical industry for an MD or with 2 or more years of clinical experience after MBBS. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries. Excellent understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology Attention to detail and quality focused Strong organizational and project management skills Strong communication skills, and the ability to operate effectively in an international environment Excellent understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process Strong technical understanding of Biomedical/Biostatics concepts 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, demonstrating initiative and flexibility through effective innovative leadership ability. Functional Manager Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Division Development Business Unit Patient Safety & Pharmacovigilance Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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