Patient Safety Responsible Manager (Maternity cover 2 years)

Job title:

Patient Safety Responsible Manager (Maternity cover 2 years)

Company:

Novartis

Job description

Job Description Summary Lead and oversee pharmacovigilance activities within the local Affiliate(s), ensuring alignment with the Sandoz Pharmacovigilance (PV) System, Patient Safety (PS) organization and operating model, and associated Quality systems. This role is pivotal in guaranteeing that local safety procedures are comprehensive, effective, compliant, and seamlessly integrated within the cross-functional and global-regional-local framework. As a key member of the local Affiliate(s) organization, you play a pivotal role in promoting a comprehensive understanding of the PV system and ensuring adherence to local safety requirements. Your high visibility within the organization enables you to effectively advocate for the local Affiliate’s needs at local, regional and global levels, ensuring robust support for all safety requirementsJob DescriptionSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Main Responsibilities and Tasks:

• 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.
• Local Pharmacovigilance Qualified Person/National Pharmacovigilance point of the contact: Serve as the Single Point of Contact or Deputy for Pharmacovigilance, ensuring 24-hour availability where required by local PV laws. Act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance, as defined by local regulations, and maintain direct communication with the Local Health Authority on Pharmacovigilance matters.
• 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.

Minimum Requirements:Education: Professional qualification in Health Care Sciences (e.g., Medical Doctor, Pharmacist) or equivalent education, training, and experience) is a must.Work Experience:

• Experience: Minimum 3-5 years in drug safety or pharmacovigilance (preferred)
• Leadership: Demonstrated leadership and achievement in all aspects of patient safety within a local/matrix environment in the pharmaceutical industry.
• Regulatory Knowledge: Extensive understanding of local and regional pharmacovigilance requirements, with the ability to address complex regulatory issues.
• Process Knowledge: Proficient in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training. Proven ability to critically evaluate and integrate data from diverse areas/domains.
• Communication: Effective communication skills with various stakeholders.
• Audit and Inspection: Experience in pharmacovigilance audits and inspections is strongly preferable.
• Innovative Thinking: Demonstrated ability for innovative and big picture thinking.
• Skills: Strong planning, negotiation, organizational, and interpersonal skills.
• Technical Proficiency: Computer/IT systems literacy.

Languages :

• Proficiency in English: Fluent level of written and spoken English.
• Proficiency in Hungarian: Fluent level of written and spoken Hungarian.

You’ll receive:Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, 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 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 supported!Join us!Commitment to Diversity & Inclusion (hard coded in Workday):We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.#SandozSkills Desired Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Model

Expected salary

Location

Budapest

Job date

Tue, 15 Apr 2025 23:34:09 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.