Patient Safety Specialist (d/f/m), Vienna (AT)

Job Description Summary

Oversight: Together with (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, develop and implement oversight mechanisms for safety activities within the local Affiliate(s), including those outsourced to and third-party vendor(s). This encompasses local initiatives such as patient-oriented programs, digital assets, and social media listening programs, as well as core safety activities like case handling and periodic/aggregate reports generation and submission. Ensure these activities are executed effectively and comply with local pharmacovigilance laws and quality standards.

With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region:

• Manage 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.
• 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. Advocate for the needs of the affiliate at regional and global level to ensure that safety requirements are well supported
• 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 to other functions in the affiliate, to ensure their safe and effective use, specifically through implementation of risk management plans and risk minimization measures.
• 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), to ensure that they are well executed and satisfy quality and compliance expectations.
• 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.

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

Your key responsibilities:

With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region:

• Manage 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.
• 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. Advocate for the needs of the affiliate at regional and global level to ensure that safety requirements are well supported
• 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 to other functions in the affiliate, to ensure their safe and effective use, specifically through implementation of risk management plans and risk minimization measures.
• 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), to ensure that they are well executed and satisfy quality and compliance expectations.
• 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.

What you´ll bring to the role:

• Professional qualification in Health Care Sciences (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
• Minimum 2 years in Pharma Industry e.g., Regulatory Affairs, Medical Affairs, safety or pharmacovigilance (preferred)
• Proven understanding of local pharmacovigilance requirements
• Advanced in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training
• Effective communication and negotiation skills
• Experience in pharmacovigilance audits and inspections desirable
• Ability for innovative and strategic thinking
• Fluent in English and German (any other language is an advantage)

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!

Imagine what you could do here at Sandoz!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, learning and development options as well as worldwide career opportunities.

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 58,199,96/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

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.

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: Job search vacanciesineu.com Sandoz

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Skills Desired

Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

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