Safety Case Manager

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 for global compliance, quality, efficiency and management of post marketing & clinical trial safety cases for products across Sandoz Group Portfolio.? Ensure development and maintenance of processes for inhouse and outsourced activities related to Safety Case management in collaboration to meet Safety case reporting regulatory requirements. Author, review and update SOPs related to Safety case management.? Interact with strategic supplier to review their performance and identify areas of development for capability building? Lead global internal audits and Health Authority Inspections taking complete responsibility for inspection readiness and timely implementation of necessary corrective and preventive actions.? Lead case management related workstreams and act as subject matter expert for cross functional projects including strategic Novartis acquisitions and mergers? Represent Patient Safety at internal and external meetings with global line-functions and third party (eg. Vigilance Agreement Partners)? Drive operational excellence to optimize business efficiency in alignment with Patient Safety?s objectives and vision? Responsible for assuring conformity with global procedures, process, and regulatory requirements for all associates of safety case management team within Sandoz and strategic suppliers.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? 5-7 years of pharmaceutical industry experience, preferably pharmacovigilance. Knowledge of drug safety regulatory requirements and general project management is desirable.? 2 years of people management and development experience is desirable.? Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.? Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.Why 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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