Stefania Vitale
Capital Federal
Summary
Since I started my working career, I have been able to develop and reach the skills in the different stages of the Pharmaceutical Chain, giving me a huge vision of a changing market, for almost 10 years. My goal, as an enthusiastic and proactive person, is to be in contact with constant dynamic challenges and to grow in my knowledge about health and its relationship between economics and marketing areas, with an integral, analytical, and strategic role. Finally, my desire is to be in contact with a team that allows us to be better people.
Overview
13
13
years of professional experience
Work History
Sr. Payer Scientific Liaison Oncology
Johnson & Johnson
05.2022 - Current
- Jan 2024 to June 2024: Grow in Strategic Access Manager with focus on BC (business case), LRFP and collaborative participation on regional meetings
- Field role, responsible for presenting medical education, exchange of scientific proposals and value proposition with payers and PHDM (population health decision makers) providing clinical and available pharmacoeconomic information with the main objective to handle and resolve evidence-based objections
- Participation in the deep understanding of patient journey data
- Providing information, training, and work as a partner to the KAMs (key accounts managers)
- Collaborating with insights to strategic access areas and HEOR
- Leader and speaker in Field Events (PSL Driven Event, Speaker Tour, Ad Boards) and follow field KPIs
- Guarantee meaningful relationships with external stakeholders (soft skills)
Sr. Biopharmaceutical Rep.
Amgen Biotechnology
11.2019 - 04.2022
- In field experience as commercial representative with scientific degree for General Medicine (Inflammatory and Bone therapies) in a high-cost market for mix sales products
- Collaborative work in teams to manage Annual Marketing Plan, trending market understanding, street mapping (targeting and segmentation of HPCs)
- Providing In-Field insights regarding market access and main stakeholders to understand gaps and opportunities for the local business
- Participation in the local Compliance Champions Team
- Leader in my own intrapreneur project for improving the marketing purpose
- Leader on Customer facing focusing on the continuous improvement to deliver medical solutions
- Cross functional work between medical and access team
Sr. Quality Assurance
Productos Roche S.A.Q.e I.
04.2018 - 10.2019
- Managing local SOPs (responsible to perform and audit)
- Responsible for the release of Commercial and Compassionate Use drugs (SAP)
- Performing and leading supplier audits
- Main point of contact for Quality assurance tasks regarding Clinical Trials
- Cross functional work between departments
Sr. Drug Formulation Development
Doena Pharma
07.2017 - 03.2018
- Quality-by-Design (QbD) based drug formulation development for a start-up
- Research and Development Pharmaceutical for small–scale manufacturing processes
Trainee in Regulatory Affairs
Productos Roche S.A.Q.e I.
05.2016 - 07.2017
- Responsible for the submission and follow up of health import licenses (ANMAT 14 Point Letters), Dossier according D.2275 and D.2674, submission of letters according D.2675, follow up tasks in ANMAT
- Point of contact with regional regulatory departments and Headquarters
- Performing product registry
- Managing SAP
- Reviewing and providing feedback to the Supply and Marketing department, according to regulatory standards to improve business continuity
- Performing local SOPs
- Interaction with locals and external partners to manage audits
Trainee in Regulatory Affairs
Merck S. A.
02.2015 - 04.2016
- Follow up product Dossiers (updates or entries)
- Proactive role in the presentation, preparation, and follow-up of regulatory files to Local Departments
- Acting as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity
- Assistance and support to commercial, marketing and supply departments, focusing on business strategy
- ICH Q9 training
- Responsible for ensuring compliance, quality and regulatory standards to avoid stockouts
- Manage SAP
- Point of contact for local regulatory agencies (ANMAT, SENASA, INV, SEDRONAR) ANMAT: Registration by 2275, revision of 14 points
- SEDRONAR: Responsible for the registration of imports, exports, monitoring, cancellations
- Psychotropic and narcotic drugs list I and II
- INV: Responsible for the activities associated with the local department
- SENASA: Responsible for all the activities in connection with the public organization
- Professional practice of the Pharmacy career in a Quality Control Laboratory
Trainee in Technical Department
Disprofarma SA
07.2013 - 11.2014
- Quality and regulatory assurance activities
- Follow up psychotropic products
- Traceability system
Pharmacy Clerk
Farmacity S.A.
06.2011 - 07.2012
Education
Pharmacist -
University of Buenos Aires
01.2016
Quality Assurance -
UBA
01.2017
Postgraduate course in Quality Assurance -
UCES
01.2019
Professional training course for Commercial REP -
Argentine School of Business, EAN
01.2020
Languages
English
Advanced
C1
Personal Information
Date of Birth: 02/27/90
Timeline
Sr. Payer Scientific Liaison Oncology
Johnson & Johnson
05.2022 - Current
Sr. Biopharmaceutical Rep.
Amgen Biotechnology
11.2019 - 04.2022
Sr. Quality Assurance
Productos Roche S.A.Q.e I.
04.2018 - 10.2019
Sr. Drug Formulation Development
Doena Pharma
07.2017 - 03.2018
Trainee in Regulatory Affairs
Productos Roche S.A.Q.e I.
05.2016 - 07.2017
Trainee in Regulatory Affairs
Merck S. A.
02.2015 - 04.2016
Trainee in Technical Department
Disprofarma SA
07.2013 - 11.2014
Pharmacy Clerk
Farmacity S.A.
06.2011 - 07.2012
Quality Assurance -
UBA
Postgraduate course in Quality Assurance -
UCES
Professional training course for Commercial REP -
Argentine School of Business, EAN
Pharmacist -
University of Buenos Aires
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