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Patient Safety Specialist

2 weeks ago

Montréal, Canada Novartis Full time

24 - The number of pharmacovigilance passionate associates waiting for you to join the Patient Safety team. The role of the Patient Safety Specialist is to support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis local and Global procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.
- Your responsibilities include, but are not limited to:
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter date from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
- Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data
- Interact and exchange relevant safety information with LHA, Patient Safety associates and other functional groups.
- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.

Please note: no relocation support available.**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams 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 education, training and experience.
- Bilingual French English: Fluent in both written and spoken is a must.
- Knowledge of national and international regulations for pharmacovigilance.
- Knowledge of pharmacological and medical terminology.
- Quality focus oriented.

The ideal location for this role is our head office site but remote work may be possible (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to our head office for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
- You’ll receive:
- Why consider Novartis?
- 769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at Novartis
- Commitment to Diversity & Inclusion:

- Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.**Division**
- Global Drug Development

**Business Unit**
- CMO & PATIENT SAFETY GDD

**Country**
- Canada

**Work Location**
- Montreal

**Company/Legal Entity**
- Novartis Pharma Canada

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes