Experience

• 

  Pfizer

  Jan 2008 - Aug 2010

  a. Responsible for Regulatory Processes with DIGEMID: preparation of technical dossiers for registration and renewal processes. Updating of approved technical dossier.b. Preparation of technical documents for regulatory changes: manufacturer, formula, source, specifications, labeling, leaflet, packaging material, packer/conditioner, contract manufacturing. c. Developing and writing clear arguments and explanations for new product licenses and license renewals.d. Participate in both brand teams (where appropriate) and strategy to drive commercial objectives.e. Maintain product compliance in line with corporate and regulatory standards.f. Special requests for product stock depletion when applies, keeping a continuous interaction with health authorities DIGEMID, Alafarpe, Chamber of Commerce, Pharmaceutical College, public and private institutions related to the company. g. Development of regulatory strategies, product strategies against copying, saving projects for the area. h. Implementation of Artworks with the support of Manufacturing Site. Show less

  • Regulatory Affairs Assistant

    Jan 2010 - Aug 2010

  • Quality Assurance Interin

    Jan 2008 - Jan 2010
• 

  Pfizer

  Jan 2011 - May 2012

  Safety data management specialist

  a. Responsible for the handling and processing of adverse events reports (serious or not serious), according to internal’s SOPs/WPs and ICH-GCP standards and coordinate reporting activities with the local regulatory agency (DIGEMID).b. Data management of serious adverse events in research, reporting to regulatory agency (INS) and proving information to Headquarters through of corporate tools.c. Establishes plans for identifying, addressing, and monitoring safety signals and communicating safety information for products in post-marketing area.d. Monitoring and collection of relevant clinical information with patients, healthcare professionals and principal investigators. e. Responsible for distribution of Individual Case Safety Reports (PSUR, SUSAR) to group of researchers, ethics committees and local regulatory agency. f. Leads and contributes to corporate initiatives through internal and external interactions in the areas of business development, global integration, alliance management, and regulatory compliance.g. Provide support in the preparation of, and during, inspections and audits. Assist with the effective management of any follow-up measure or outcomes of audits and inspections.h. Develop and maintain an effective Pharmacovigilance archiving process and ensure that all data is kept in an inspection and audit ready state at all times.i. Training for administrative staff and sales force in relation to safety drug and reporting responsibilities and develop and maintain an active interface with internal colleagues to ensure that they are kept informed of pertinent Pharmacovigilance issues Show less

• 

  Novartis

  Jun 2012 - now

  Ensure quality governance and quality planning in the CPO in alignment with the CPO QA Head directions for Pharma Division and for any other Novartis Division in according to signed Service level Agreements (SLAs) through the implementation of quality system and process and the annual quality plan. Act as Technical Director and to prevent quality or regulatory non-compliance issues which could lead to product stock out or withdrawal.Responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV), as well as GxP activities related to Marketing (e.g. HE/OR, POPs etc.) Ensure in direct collaboration and partnership with the CPO Medical Department (including GenMed, Oncology, DS&E, DRA and Medical Affairs) and Marketing Departments the implementation of the Novartis Quality Management System in the CPO to achieve a high level of quality and compliance. Show less a. Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Novartis Quality Manual and the Quality Plan.b. Keep abreast of regulatory requirements, and update local management and Pharma Development at Medical Affairs areas (GCP and GPvP) on the possible ramifications of regulatory changes and impact to Clinical Development, Medical Affairs and Pharmacovigilance processes.c. Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators and assure that gaps are addressed appropriately in order to mitigate risk. d. Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, Medical Affairs (MA) and pharmacovigilance (PV) activities. Ensure the supplier selection process properly followed at the country. e. Coordinator about preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.f. Check and release of Investigational Medicine Product according to regulatory requirements.g. Analysis of GCP compliance trends in investigational sites, in order to evaluate and schedule audit process. Show less

  • Country GDQ Manager, Technical Director

    Mar 2018 - now

  • QA Manager Development, Technical Director

    Jan 2016 - Feb 2018

  • QA & Development Responsible Ecuador - Peru / Technical Director

    Aug 2014 - Dec 2015

  • Development Quality Assurance Responsible Ecuador / Peru

    Jun 2012 - Jul 2014