Spécialiste, Sécurité des patients
Location
Boucherville, QC | Canada
Job description
About the role
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!
As the Specialist, Patient Safety, you support management of Patient Safety operational processes at a local and regional level, in collaboration with and oversight of a 3rd party vendor, to ensure operational excellence and compliance with Sandoz global and local procedures, national and international regulations for vigilance of both marketed and investigational products from Sandoz in Canada.
Your responsibilities include, but are not limited to:
• Manage the collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports for all Sandoz products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, spontaneous reports and all other sources of information.
• Transcribe, translate and enter data from source documents into safety systems accurately and consistently with quality emphasis and timeliness.
• Liaise with respective external service providers to ensure compliance with Sandoz procedures, where case processing activities are outsourced.
• Manage reporting/submission/distribution of safety reports/updates/information (e.g., Serious Advserve Event, Annual Summary Report, etc.) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
• Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Interact and collaborate with other departments (such as Medical Affairs, Marketing, Patient Engagement, etc.) to ensure that any projects/ initiatives involving safety data collection follow the Sandoz vigilance requirements.
• Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary.
• Perform reconciliation with other departments (e.g., Medical Information, Quality Assurance, and Third-party contractors, as applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Develop and update training materials for vigilance and ensure training of Sandoz Canada associates on relevant Patient Safety procedures for AE reporting, including field force and third-party contractors, as applicable.
• Ensure support to the internal audits, Health Canada inspections and implementation of the respective CAPA plan.
Role Requirements
What you need for this role :
• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent, with a minimum of 3-5 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
• Bilingualism, English and French, both spoken and written.
• Knowledge of national and international regulations for pharmacovigilance
• Quality and results oriented. Rigor and attention to detail.
• Curious, willing to learn.
• Ability and willingness to work as part of a team.
• -Project management skills, an asset
Why consider 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!
#Sandoz
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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