Patient Safety Specialist

hace 1 mes


Tlahuac, México SDZ MEX A tiempo completo

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
- 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.
- To support management of operational processes in ensuring compliance with global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational products.
- Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all 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.
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
- Education (minimum/desirable): Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
- Languages: Fluent in written and spoken English.
- Fluent in written and spoken local language.
- Experience/Professional Requirement:Minimum 2 years’ experience in drug-safety or pharmacovigilance and/ or experience in pharmaceutical industry.
- 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

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



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