Senior Medical Safety Lead (Sandoz)

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:? 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).? Preparation/review of investigator notifications and periodic medical assessments for ethics committees. Medical review of single case reports according to business needs (example SUSARs)? Review safety documents prepared by External Service Providers. Performs medical assessment of product quality defects with or without adverse events, including the review of line listings whenever required and proposes relevant market action.? Monitoring and evaluation of all safety signals both from internal and external sources including literature sources, single cases and/or aggregate data and presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.? Prepares safety responses to inquiries from regulatory authorities, health care professionals or legal queries on the benefit-risk balance of assigned products. Supports Country Organization and other stakeholders on safety related questions when global input is required.? Depending on assigned products and portfolio, may support the GPSL/Medical Safety Group Lead and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL.? Lead/Review 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 inputs and collaborates on preparation of Safety Profiling Plan (SPP)Diversity & 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 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.? Relevant experience (e.g., clinical, postdoctoral) after graduation.? At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) is desirable.? Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.? Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information? Experience with (safety or others) issue management and decision making on safety topics.#orbitWhy Sandoz?500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 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.How will we do this? 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 achieve here at Sandoz!Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Join our Novartis Group 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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