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.
• E xperience 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.

ROLE PURPOSE

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 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.