Job Description 766 million lives were touched by Novartis medicines in 2021, 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.
To support management of Patient Safety (PS) 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).
Roles and Responsibilities
1. Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, 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.
2. 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.
3. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
4. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
5. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
6. Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
7. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
8. 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.
9. Drives the local execution of the Risk Management Plans (RMP)/ Risk Evaluation and Mitigation Strategy (REMS) for all Novartis group products in United States:
• Ensures training on RMP/REMS principles and RMP/REMS product specifics of Country Organization staff (incl. Sales/Marketing staff) involved in the implementation of the RMP/REMS
• Supports the Drug Safety Responsible in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP/REMS
• Liaises with the other departments in the Country Organization such as Clinical Research Operations, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the RMP/REMS
• Liaises with Sales/Marketing to ensure implementation of educational materials