Medical Safety Specialist

Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it?s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.Your responsibilities include, but are not limited to:? Provide support according to the needs for delivery activities, 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/MSE 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.? Support Literature review for PSUR inclusion and assessment of literature for signals. Together with the Safety Leads, co-author the PSUR sections as required.? Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA? Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Risk Management Plan (RMP), Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).? Support the safety lead with medical assessment of product quality issues (e.g. - Filling out relevant sections of the MRA)? Support in preparation of responses to internal safety requests and contribute to responses to external safety queries. Writing of meeting minutes. Document archival and formatting? Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updatesDiversity & Inclusion / EEONovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum Requirements? Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate? Fluent in spoken and written English. Understanding in another major language (e.g. French, German, and Spanish) desirable.? 3 years in patient safety. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries? Good understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology? Attention to detail and quality focused; Good communication skills, and the ability to operate effectively in an international environment? Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process? Good presentation skills; Good computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applicationsWhy 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 whats 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

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