Assoc. Director Patient Safety Hub Latam
hace 3 semanas
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:
- Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.
- Participates in the resolution of any legal liability and in complying with government regulations.
- Ensures accurate receipt, maintenance and assessment against product labeling.
- Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports.
- May provide trending and safety signal detection and assessment & Supports all clinical trial activity and post marketing.
**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**
- Degree in Health Sciences or higher, including medical degree, pharmacy, or nursing.
- Fluent in both written and spoken English & Knowledge of other languages desirable
- Minimum 7 years medical, pharmaceutical, clinical and/or scientific research experience with at least 5 years related experience in clinical pharmacovigilance/pharmacovigilance requirements or regulatory compliance
- Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety at the local and global level in a matrix environment in the pharmaceutical industry
- Thorough understanding of clinical drug development process -Strategic and critical thinking in establishing pharmacovigilance oversight in the region
- Advanced leadership experience in working and leading multi-disciplinary or cross-functional team and influencing others in a matrix organization
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
**Country**
- Mexico
**Work Location**
- Distrito Federal
**Company/Legal Entity**
- SDZ MEX
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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