As Patient Safety Specialist, you will manage pharmacovigilance activities in the Sandoz affiliate in Portugal in the context of the Sandoz Pharmacovigilance System, the Sandoz 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. Additionally, there will be a 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. Collaborate closely with local QPPV (provided by external partner or partner function).
Influence the affiliate organization as a key member of the affiliate organization with high visibility, to promote 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 - drugs and combination 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 (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).
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:
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 (preferred) and/or experience in the pharmaceutical industry.
Demonstrated leadership and accomplishment in patient safety or 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 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 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, innovative 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!
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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