Patient Safety Specialist
hace 2 meses
Job ID- 366180BR- Mar 04, 2023- Mexico**Job Description**:
- 2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength 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 impactThis is one such role
- Are you ready to make a difference?
- Your key responsibilities:
- To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.
- Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
- Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
- Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments
- Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
- Work with other local/global PV associates to ensure accurate evaluation of safety data. -Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
- Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
**Diversity & Inclusion / EEO**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._
**Minimum Requirements**:
- Education - Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience.
- Languages: Fluent in both written and spoken English & Spanish
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Good communication and interpersonal skills
- Quality and results oriented -Project management skills
- Computer skills
- 2 years as Patient Safety Specialist (preferred)
ORBIT
What you’ll bring to the role:
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 ambitiouslytackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never tryingImagine what you could achievehere at Sandoz
Division
- SANDOZ
Business Unit
- Commercial OPS SIR SZ
Location
- Mexico
Site
- Distrito Federal
Company / Legal Entity
- SDZ MEX
Functional Area
- Research & Development
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
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