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Deborah C
Compliance & Transparency – Italian Office
Overview of Experience
I am detail and solution orientated, with strong organizational and project management skills.
I have successfully carried out experiences as a Project Leader and Cross-Functional Group Coordinator for more than 15 years in the publishing industry and since 2008 in pharmaceutical sector.
Within the pharmaceutical industry, I have carried out a number of cross-functional activities within the Legal, Ethics & Compliance Department, and the Medical Information Team.
I have supported complex and sensitive business projects (e.g., related to corporate governance, contract & procurement, T&E procedures) whilst keeping in close contact with business stakeholders.
Areas of Expertise
Ethics & Compliance
EFPIA Transparency
Training
Track Record
EFPIA Transparency: Italian affiliate contact point:
Review of internal workflows/procedures;
Support for the update of methodology notes;
Development of action plans, and project timelines;
Coordination with company stakeholders (including the Senior Leadership Team);
Trainings: development of materials, delivery of training sessions (inductions, updates) to cross-functional team who are involved in the transparency program;
End-to-End data management process: Data Collection, Data Remediation, Data Review, Report Preparation (draft and final report).
Collection and checking of data for yearly Transfers of Values publication (direct/indirect): financial data originated by management software or tools (SAP B1 Ariba, Concur, Share Point, Veeva), master data files, invoices, HCP/HCO contracts.
Checking the Consents are accurate and complete;
Follow up on missing reportable items and amendment based on feedback;
Pre-report data quality checks;
Final data review and report mock-up to be approved and certified through designated tool.
Support and liaison for dispute resolutions and report updates;
Advising on local reporting requirement updates (e.g., the new transparency law expected in Italy for 2024, Italian Sunshine Act, different publication timeline…).
Legal and Ethics & Compliance:
Coordination of pharmaceutical company’s governance activities according to Italian law and acting as the point of contact for corporate bodies (Board of Directors, Board of Statutory Auditors, Shareholders).
Adaptation and support for ethics and compliance training, promoting corporate culture, and assisting in the review of procedures and approval workflows.
Knowledge of the legislative regulations related to Health Care Professional (HCP) engagements and Healthcare Organisation (HCO) sponsorships, monitoring the correct archiving of documentation and/or public administration authorizations, when necessary.
Software & Tools
Setup, local adaptation and implementation of management tools:
Veeva Suite (CRM, Events, Veeva PromoMat…)
SAP and SAP B1 – Ariba Procurement & Contract Management
Concur
Microsoft suite