Safety Case SME

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.Your responsibilities include, but are not limited to:? Responsible to monitor all case processing related activities to facilitate oversight on Strategic supplier?s quality and compliance of deliverables? Support audits/Inspections as Subject Matter Expert, and develop, monitor and implement Corrective and preventative Actions (CAPA) to address safety findings? Support audit and inspection readiness within the internal and strategic supplier teams supporting case management? Develop, contribute and maintain guidance documents including providing inputs to PVA and other such safety management plans? Train and mentor new PS associates and associates from other line functions. Collaborate with Data Management team to enable reconciliation for locking of Clinical database? Support Patient Safety departments, License partners and medical safety to ensure that reports are accurately collected, evaluated and data based? Support the testing activities for case processing related safety systems/IT applications. Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products? Support Operational Projects or database validation activities as required. Identify any non-conformity with global procedures, process, and regulatory requirements related to safety case management within Sandoz and strategic suppliers and handle them as per QMS processes.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? Three years of pharmaceutical industry experience, preferably pharmacovigilance. Knowledge of drug safety regulatory requirements and general project management is desirable.? Good professional verbal and nonverbal communication skills? Strong negotiation and ability to operate effectively in a global environment and across line functions? Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.? Strong operational and project management skillsWhy 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 do here at Sandoz!Sandoz is committed to building an outstanding, inclusive work environment and diverse team?s representative of the patients and communities we serve.Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.No video provider was found to handle the given URL. See the documentation for more information.

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