Safety Case Manager

Job title: Safety Case Manager

Company: Novartis


Job description: Job Description Summary Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!Safety Case Manager is responsible for ensuring end to end Safety case management in compliance with reporting timelines and quality standards. This includes

• Leading and developing team, responsible for oversight and control of all clinical trial and post marketing safety cases handled by Sandoz’s and its strategic suppliers.
• Ensure compliance with reporting timelines and quality standards which are under the control of patient safety operations.
• Manage interfaces with other internal and external stakeholders (e.g., Global line function senior management, investigator sites, Vigilance Agreement Partners (VAP) to ensure consistent processes, efficient handling of safety case reporting, regulatory compliance, operational productivity, timelines, and quality of safety information.

Job DescriptionYour Key Responsibilities:Your responsibilities include, but 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.
• Lead recruitment, objective setting, and performance management of direct reporting associates.
• Setup and maintain training plans for new hires accordingly to job role and responsibility.
• Lead/support continuous improvement, quality, productivity, and innovation leveraging internal and external people, process and technology
• Contribute to talent retention strategy and development team members.
• Deputize for Head Case Management and Aggregate Reporting as needed.

What you’ll bring to the role:Essential 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.Skills:· 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?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Skills Desired Clinical Trial, Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Team Management, Waterfall Project Management

Expected salary:

Location: Telangana

Job date: Fri, 11 Oct 2024 06:22:16 GMT

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