Specialist, Patient Safety

2 weeks ago

Montréal, Canada Sandoz Full time

#1 in the Canadian Generic & Biosimilar drug market is what Sandoz Canada is aiming for Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world? 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 will include, but are not limited to:
- Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Sandoz products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs)s, Literature, Spontaneous Reports, and any other source of information. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness. When case processing activities are externalized, liaise with the respective External Service Providers to ensure Sandoz procedures’ compliance.

Your responsibilities include but not limited to:
- Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) 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 (POPs, DEAs, SM/SML, etc.) 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.

**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._

**Minimum requirements**
- What you'll bring to the role:
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent, with a minimum of 2-3 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
- Bilingualism, English and French
- Knowledge of national and international regulations for pharmacovigilance
- Quality and results oriented
- Project management skills
- Computer skills

You’ll receive:
- Why Sandoz?
- At Sandoz Canada, we have the wellbeing of our colleagues at heart: we offer flexible work arrangements and competitive advantages. We can gladly discuss during our initial conversation.
- Sandoz Canada is a very dynamic organization where our people are at the center of our activities.
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Sandoz

**Division**
- SANDOZ

**Business Unit**
- COMMERCIAL OPS NA SZ

**Country**
- Canada

**Work Location**
- Montreal South Shore - Boucherville

**Company/Legal Entity**
- Sandoz Canada

**Functional Area**
- Research & Developme

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