Job Description Summary
We're looking for a Patient Safety Specialist for Portugal.
Job Description
As Patient Safety Specialist, you will manage pharmacovigilance activities in the Sandoz affiliate in Portugal within the context of the Sandoz Pharmacovigilance System, the Sandoz patient safety operating model, and associated quality system. This ensures that local safety procedures are comprehensive, effective, compliant, and well-embedded in the cross-functional and global-regional-local environment. Additionally, there will be close collaboration with team colleagues in Spain.
Your responsibilities will include:
Lead pharmacovigilance activities in the Sandoz affiliate, ensuring 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, promoting a thorough understanding of the pharmacovigilance system and adherence to safety requirements for local activities.
Ensure the seamless flow of safety relevant information within the affiliate, with local business partners, and with regional hubs and 3rd party vendors 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.
Establish or participate in oversight mechanisms on safety activities , specifically those outsourced to vendors on behalf of the affiliate.
Participate in the maintenance of the local quality management system , including training, records management, regulatory intelligence, and audit and inspection readiness, in collaboration with local, regional, and global functions, business partners, and vendors.
What you'll bring to the role:
Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
Minimum 2 years' experience in drug safety or pharmacovigilance and/or experience in the pharmaceutical industry.
Demonstrated leadership and accomplishment in patient safety or a similar role in a local/matrix environment in the pharmaceutical industry.
Knowledge of national and international regulations for pharmacovigilance.
Knowledge of pharmacological and medical terminology.
Good communication, strong planning, negotiation, organizational, and interpersonal skills.
Project management skills.
Fluent in English & Portuguese. Additional valued languages are Spanish.
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. With investments in new development capabilities, innovative production sites, 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 are powered by an open, collaborative culture driven by our talented colleagues, who experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and personal growth is encouraged!
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Pioneering access for patients
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: Sandoz Talentpool (novartis.com)
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Skills Desired: Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Project Management
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