Job Description

About The Role 2023, Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, hardworking organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz are you ready to make a difference Position Purpose: Provide support to the Medical Safety Leads (MSL)/Global Program Safety Lead (GPSLs)/ Group Head, Medical Safety Operations 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 Accountabilities: Provide support according to the needs for delivery activities, i.e. SUSAR ICSR medical review when needed, 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 GPSL/MSL 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. Perform Literature review for PSUR inclusion and assessment of literature for signals.Provide support for the preparation of ad hoc Health Authority queries, provide input into responses to inquiries from health care professionals on safety issues. Together with the Safety Leads, co-author the PSUR sections as required, 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. Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), support maintenance and management of local deviations to Global CDS (SMPC, USPI, Japanese PI) 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). Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs). Provide safety input (Addendum to Clinical Overview) for license renewal documents.Co-author medical assessment of product quality issues.Contribute to the development and update of RMPs in collaboration with MSL/GPSL, coordination with other functions Prepare responses to internal safety requests and contribute to responses to external safety queries. Act as Subject Matter Expert (SME) for Medical Safety Expert Operations/ Medical Function (participation in initiatives). Lead the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels. Provides guidance as appropriate to Case processing team for the coding and causality/expectedness assessment of adverse event reports as and when needed. Provides support as needed for regulatory authority inspections and internal/external audits. Assist in Root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) as appropriate. Preparation and review of working instructions and procedures. Support the MSL/GPSL in their assigned projects and deliverables. Perform duties as per assigned project/workstreams within Medical Safety. 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 Education (minimum/desirable): Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity. Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, and Spanish) desirable. Experience/Professional requirement: For life sciences graduate - 3 years in patient safety at an operational or medical position 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 strict timelines, demonstrating initiative and flexibility through effective innovative leadership ability. Why Sandoz Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. We are at a pivotal moment in our history giving us the freedom to invest in our future, so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an aspiration environment with impact, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Division SANDOZ Business Unit NON-NVS TSA SANDOZ GLOBAL DEVELOPMENT Work Location Hyderabad, AP Company/Legal Entity Sdz Pvt Ind Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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