Global Program Safety Lead

Job Description

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.? Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities. Is responsible for initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.? Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues. Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members. Prepares safety data for health authority review boards (together with the clinical and biostatistical functions). Attends Health Authority Meetings in person, as required.? Is responsible for responses to legal queries and Country Organization (CO) requests involving safety issues. Provides integrated safety input into all regulatory documents required during active development. Ensures safety information is communicated/escalated to HPS/MPH, HMS HYD and/or EU Qualified Person in a timely fashion.? Facilitates involvement of external experts (e.g. authors of white papers, members of trial- specific data safety monitoring boards, ad-hoc support for HA meetings, etc.). Prepares and presents safety issues to internal Sandoz Boards and other meetings as required.? Provides relevant input for SMT/SMB, GPT, GCT and CTT meetings as needed. Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within Patient safety and those from other functions, (e.g. Clinical Development and Medical Affairs, Regulatory Affairs, Medical Information) as well as externally with expert panels and other scientific contacts.? Provides expert medical input to trial and project level Drug Safety Monitoring Board/Data Monitoring Committee and Safety Adjudication Committee activities for assigned projects/products, as required.? Performs tasks assigned as per applicable procedures assigned to the role. Keeps working instructions / SOPs / GOPs for the area of responsibility up to date withinternal (e.g., QMs) and external (e.g., GVP modules) requirements, provides input to such procedural documents of other functions, and ensures implementation of such procedural documents in the area of responsibility.? Provides support as needed for licensing activities, regulatory authority inspections and for project /product recall activities. Leads the day-to-day safety activities and provides guidance to junior personnel. Proactively engages in the development of competencies across the Medical Safety Function.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? 3 years postdoctoral clinical practice; Minimum 8 years medical, pharmaceutical, clinical and/or scientific research experience with at least 6 years in Global drug development including at least 5 years in drug safety.? Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.? Experience with (safety or others) issue management. Thorough understanding of clinical drug development process. Strategic and critical thinking in establishing product safety profile and benefit-risk? Advanced leadership experience in working and leading multi-disciplinary or cross-functional team and influencing others in a matrix organization? Proven ability to work and handle multiple tasks independently and effectively. Excellent communications, interpersonal and negotiation skills (confident and articulate)? Quality and focus oriented. Results driven, self-starter with proactive working style, committed and accountable, transparent working style under pressure? Cultural sensitivity, patient but persuasive, cultural fit with Novartis/Sandoz values. Planning, organizational and computer skills#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/networkNo video provider was found to handle the given URL. See the documentation for more information.

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