Aurélia N.

• - Collect, process, document, report, and follow-up of all adverse events for all Novartis group products and ensure accurate evaluation of safety data

• - Survey and monitor national pharmacovigilance regulations

• - Facilitate the reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources

• - Develop and update training materials for pharmacovigilance

• - Supports the RMP manager in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP

• - Perform periodically the local signal detection

• - Perform periodically the "off-label use" monitoring (French requirement)

• - Provide the scientific expertise for compassionate use program implementation including contract/ agreement review and ensure periodic pharmacovigilance activities are fulfilled after initiation

• - Write/ review the safety parts of regulatory reports: Periodic or ad hoc safety reports, MA registration or variation, price and reimbursement dossier...

Project management in pharmacovigilance and other vigilances (MD, cosmetics) including individual cases management, signal detection, periodic reports.

Responsibilities & involvement in:

- Project operational activities

- Project quality control (including operational deliverables)

- Deliverables validation

- Team training and management (global and project level)

- Quality documentation updates including process improvement (global and project level)

- Time schedules and resources management

- Contracts and finances

- Communication/Coordination with clients

Main operational expertise in case management. Collaboration on the set up of a MD database for alignement to the European Regulation

Clinical trials and post-marketing pharmacovigilance:

• - Receive, triage, review and process safety operational data from various sources on time

• - Perform data entry for tracking and safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines.

• - Review, assess and process safety data and information and distribute reports/data onwards to third parties following applicable regulations SOP's and internal guidelines.