Patient Safety Manager

Job Description

Sandoz 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!

This is a temporary role for a period of 12 months only.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• 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.
• 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.
  
  

Essential Requirements

What you’ll bring to the role:

• Medical Doctor, Pharmacist or equivalent education, training, and experience
• Minimum 5 to 7 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
• Minimum 2-3 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.
• Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.
• Computer/IT systems literacy.
• Certified level of written and spoken English.
• Good working knowledge of local language.
• Knowledge of other languages (desirable).
  
  

You’ll Receive

Be part of a supportive and inclusive work environment that values your growth and contributions. Flexible working environment tailored to field-based roles, allowing you to manage your schedule effectively. Gain extensive learning and development opportunities, along with valuable scientific experience, within a dynamic multinational company.

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

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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