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Manager Patient Safety Italy

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Sandoz

2mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Consulting
    Healthcare
  • Milan

AI generated summary

  • You need a medical degree or equivalent, fluent Italian and English, 3-5 years in pharmacovigilance, 2-3 years in leadership, knowledge of PV processes, audit experience, and strong interpersonal skills.
  • You will manage pharmacovigilance communications, oversee safety activities, maintain product safety awareness, ensure compliance, and support quality management systems with local partners.

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.

Responsibilities

  • 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.

FAQs

What is the main purpose of the Manager Patient Safety role at Sandoz Italy?

The main purpose is to lead pharmacovigilance activities in the Sandoz affiliate to ensure local safety procedures are comprehensive, effective, compliant, and well-embedded across the organization.

What are the key responsibilities of the Manager Patient Safety?

Key responsibilities include acting as the single point of contact for pharmacovigilance, overseeing safety activities, maintaining awareness of product safety profiles, and ensuring compliance with local safety requirements.

What are the essential qualifications required for this position?

Essential qualifications include a Medical Doctor or Pharmacist degree, excellent knowledge of Italian and English, and a minimum of 3 to 5 years' experience in drug safety or pharmacovigilance.

Is leadership experience required for this role?

Yes, a minimum of 2 to 3 years of demonstrated leadership in patient safety within the pharmaceutical industry is required.

What type of work environment can I expect at Sandoz?

You can expect an inclusive work environment that values diversity and encourages personal growth within a collaborative culture.

Will there be opportunities for professional development?

Yes, employees will receive customized development paths, free access to training catalogs, and opportunities for job rotation projects.

How does Sandoz handle work-life balance?

Sandoz offers a hybrid work model based on flexibility and trust to help maintain work-life balance.

Can I expect to receive compensation for my contributions?

Yes, there is a Recognition Program in place to highlight your impact on the organization.

What type of projects will I be involved in?

You will participate in interdisciplinary global projects that involve leading, planning, and prioritizing activities on multiple initiatives.

How does Sandoz approach patient safety?

Sandoz is committed to maintaining high standards in patient safety through effective pharmacovigilance practices and compliance with local regulations.

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

Sandoz, a global leader in generic pharmaceuticals and biosimilars, is dedicated to improving access to high-quality, affordable medicines for patients worldwide. Their ultimate mission is to expand access to essential healthcare by developing and providing generic and biosimilar medicines that meet rigorous quality standards. Sandoz aims to make healthcare more accessible and affordable, ensuring that patients benefit from high-quality treatments and contributing to the overall improvement of global health outcomes. Their purpose is to enhance the quality of life for people by delivering cost-effective, innovative solutions in the pharmaceutical industry.