Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients. We are looking for highly energized, passionate people to join the Patient Safety Team to improve the care of our patients.
As a Patient Safety Specialist, you will support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group, marketed and investigational products (drugs and devices).
Specifically, the role if focused on handling pharmacovigilance activities for Patient Oriented Programs in the Country Organization.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Reports for all Novartis 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 reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) 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, other functional groups and third party contractor, if applicable.
• Survey and monitor 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 necessary 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 team’s representative of the patients and communities we serve.
What you’ll bring to the role:
• Fluent in both written and spoken English
• Fluent in both written and spoken local language
• Experience on a GxP role from 6 months to 1 year is an advantage
• Knowledge of pharmacological and medical terminology
• Excellent communications, interpersonal and negotiation skills
• Quality and focus oriented
• Computer skills
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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 do here at Novartis!