Achievements:- Performed the FURP role of POP ESP, VAPs PV audits, and supported development of complex CAPAs.- Provide QA input to commercial activities with Pharmacovigilance impact namely Patient Oriented Program, Social Media Listening/Digital Assets.- Support PV transition of newly acquired company/merge & acquisition deals.- Review transition plans, risk assessments, work instructions, etc.Audit and Inspection Management:- Prepare for, facilitate, and lead Health Authority PV inspections at USA & Canada site. Assess results of pre-inspections and audits- Preparation activities and findings in terms of associated risks and communicate to management, provide input to CAPA to ensure quality, consistency and appropriateness of commitments across the pharma PV system.- Proven experience in compliance related remediations, in-depth knowledge of the GxPs, quality management concepts, risk management techniques.- Support initiatives focused on quality, process, and compliance improvement.- Support PV Management team with initiatives focused on inspection readiness.

Manage the Patient Safety operational processes at the Country Organization ensuring compliance withNovartis global and local procedures, national and international regulations/ standards/ guidelines for thevigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).

Safety management of marketed drug and medical devices, ensuring compliance with standard operating procedures according to both global and national regulations

Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for allNovartis group products and medical devices 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.

Process of ICSRs (Individual Case Safety Reports), including: reportability assessment, tracking, database entry (Argus), coding, narrative generation, and query management, all according to GCP/ICH, local SOPs and regulation to ensure compliance with Health Authority.

- Case Processing: performed case receipt, case triage and processed adverse event using ArisG.- Performed follow-up via telephone contact with health care professionals- Coding relevant medical terminology composed descriptive narrative and generated advanced conditionqueries.- Quality control check of adverse event for accuracy and completeness.