Specialist Patient Safety
2 months ago
Job ID- 366290BR- Mar 03, 2023- Australia**Job Description**:
- 70 million With over 70 million packs across 600 product lines - make a mark on every patient experience. Be part of a team that ensures quality use of medicines for the fastest growing generic in Australia. Come work for a team that feels supported and challenged by their peers and learning and growing together is part of our culture.
- Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact
- As a Patient Safety Specialist, you will support management of Patient Safety operational processes at Country Organization in ensuring compliance with Sandoz global/local procedures, national and international regulations, / standards/ guidelines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Sandoz Group.
- Your responsibilities 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 Programs, literature, Spontaneous Reports, etc.
- Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
- Manage the reporting and submission of safety reports to the Local Health Authorities (LHA) and/or clinical operations in collaboration with other Country Organization Departments.
- Work with other local and global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third-party contractors, if applicable.
- Survey and supervise national pharmacovigilance regulations and provide update to global Patient Safety organization.
- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Input, review and approval of program proposals for language, content and establishment of vital controls on collection and reporting of adverse event information.
- Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources
**Diversity & Inclusion / EEO**:
- 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:
- 2 years’ experience as Patient Safety specialist
- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
- Knowledge of national and international regulations and terminology for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Excellent communications, interpersonal and negotiation skills.
- Quality and focus oriented and possesses a high level of digital literacy
ORBIT
- You’ll receive: (not mandatory) Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
- Why Sandoz?500 million patients were touched by Sandoz generic and biosimilar medicines in 2021and 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 achieve here at SandozDivision
- SANDOZ
Business Unit
- Commercial OPS SIR SZ
Location
- Australia
Site
- Sydney
Company / Legal Entity
- AU Sandoz Pty ltd
Functional Area
- Research & Development
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
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