Hello!

Education:

I hold a Bachelor’s degree in Biochemistry, a Master’s degree in Oncology, and a Ph.D. in Cancer Cell Biology from the University of Nottingham, U.K. 

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Industry experience in pharmacovigilance:

I started in post-marketing PV operations (i.e., safety case management and reporting) for a global Japanese pharmaceutical company. During this time, I was also involved in the integration of PV operational activities of another global Swiss pharmaceutical company following its acquisition and for the safety management of several acquired phase IV clinical studies.

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Following successful integration activities, I moved on to a PV Scientist position in the same company where I worked with Safety Physicians to monitor the safety profile of several products in phases I-IV, which involved:

• Aggregate report (PSUR/PBRER) production and update

• Risk Management Plan update including writing the first version of a development RMP

• Additional Risk Minimisation Measures activities such as creating DHPC

• Literature monitoring and review, including setting up the search strategies

• Signal Detection and Management

• MedDRA coding

• Company Core Safety Information/Labelling updates

• Responding to Health Authorities’ requests

• Data Safety Monitoring Board activities

• Inspection support

 

Industry experience in PV Quality Assurance:

My working experience in PV complemented my next move to PV QA, where I have held several PV Auditor positions at global pharmaceutical companies; I conducted audits worldwide and supported onsite and remote Health Authority inspections and other activities, for example:

• End-to-End audit management

  • PV System/Process

  • PV Vendors and Service Providers

  • Licensing Partner

  • Affiliates

• CAPA Management

• Risk assessments for GVP Audit Programme

• Risk assessment tool development and implementation

• Inspection support in GCP and GVP

  • Inspection requests management, QA reviewer, Scribe, Ad-hoc support

  • EMA, MHRA, MPA, FDA, Health Canada

• Inspection Readiness Training for cross-functional teams

• Continuous Improvement activities

• Compliance metrics development

• Working knowledge of FirstDoc, Trackwise, Veeva systems and Audit Utopia

• Management and oversight of service providers

 

Audit experience in:

• Asia Pacific: China, India, Japan, South Korea, Taiwan, Thailand

• Australaisa: Australia

• Central Asia: Kazakhstan

• Europe: Austria, Bulgaria, Cyprus, Czech Republic, Estonia, France, Germany, Latvia, Lithuania, Netherlands, Portugal, Romania, Slovakia, Sweden, Switzerland, United Kingdom

• Middle East: Israel, United Arab Emirates (Dubai)

• Latin America: Argentina, Brazil, Columbia, Mexico

• United States

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