Manager Patient Safety Italy Milano

Manager Patient Safety Italy
Milano
Lombardia, Milano

Lead pharmacovigilance activities in the Sandoz affiliate, in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment.

This includes management of local Safety information like Adverse Events, PSURs, local literature and support of business to correctly set up programs and market research.

Your Key Responsibilities Your responsibilities include, but not limited to: Act as single point of contact: as defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country and act as the single point of contact with the Local Health Authority. Establish or participate in oversight mechanisms on safety activities, specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation). Ensure the seamless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model. Maintain awareness on safety profiles of Sandoz products and provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate including local implementation of RMP measures. Influence the affiliate organization as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities. Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

What you'll bring to the role:

Essential Requirements: Medical Doctor, Pharmacist or equivalent education, training, and experience. Certified level of written and spoken English. Excellent knowledge of Italian language. Minimum 3 to 5 years' experience in drug-safety or pharmacovigilance (preferred) and/or experience in pharmaceutical industry.

Minimum 2 to 3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.

Extensive knowledge of regional and local requirements relating to PV.

Ability to solve complex regulatory issues and requirements.

Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training.

Proven ability to critically evaluate and integrate data from a broad range of areas/domains.

Ability to effectively communicate with different stakeholders.

Experience in PV audits and inspections.

Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.

Strong planning, negotiation, organizational and interpersonal skills.

You'll receive: Customized development paths and free access to our on-demand training catalogs. Job rotation projects that will give you the opportunity to collaborate with global teams. Corporate Welfare Plan. Recognition Program to highlight your impact for the organization. Hybrid Work Model based on flexibility and trust. 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! Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

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