Experience

Angitia Biopharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Pharmacovigilance, Compliance, Head of US Site operations

  • Mar 2022 - Present



Alpha Medical

• Romania
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Head of Clinical and Patient Operations

  • Aug 2021 - Mar 2022

• Director of Clinical Operations and BD

  • Sep 2019 - Aug 2021

  Business Development and StrategyClinical PharmacyProvider partnershipProduct developmentGrowth strategy



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Strategic Planning and Operations, Chief of Staff

  • Nov 2017 - Sep 2019

  Resource and Budget ManagementDevelop and maintain business relationships across departments Work with the VP to set department goals and objectivesDevelop and organize staff development opportunitiesStaff development

• Global Periodic Reports Scientist

  • Oct 2015 - Nov 2017

  Continuous process improvementVendor managementQuality ManagementWork with cross-functional and global teamsQuality metrics (KPI, KCI, SLA)Inspection and auditsDeveloped and implemented IS solutions for business needs/processesCAPA

• Global Pharmacovigilance Scientist

  • Jan 2014 - Oct 2015

  Benefit-risk assessmentGlobal labeling (CDS, USPI, PIL, SmPC etc)Perform signal detection activities and risk management activities (risk management plan, REMS, PASS)Provide strategy and author responses to global health authority requestsWork extensively with cross-functional team and provide inputs for global submissions of late phase and marketed products (BLA, MAA, sBLA)Participate in the development and assessment of human factor evaluation Evaluate MedDRA search strategyWork with Early development, Late stage and post-marketing productsWrite and review periodic report (DSUR, PSUR/PBRER, PADER)Review study protocol, ICF, SAP, CSR, statistical output TFLs, IB, SOP, CRFOrganize and lead safety discussion (including preparation and presentation of data to peers, management, and senior management, advisory board)



Genzyme

• 1 - 100 Employee

• Global Pharmacovigilance and Epidemiology Fellow

  • Jul 2012 - Dec 2013

  Risk Management (REMS, RMP)Regulatory filing (FDA, EMA), FDA Advisory CommitteeAggregate Safety Report (e.g. PBRER/DSUR/ASR), Safety surveillanceRegulatory responseInvestigator BrochureProtocol developmentProject managementMedical WritingDevelop training materials for call centers Risk Management (REMS, RMP)Regulatory filing (FDA, EMA), FDA Advisory CommitteeAggregate Safety Report (e.g. PBRER/DSUR/ASR), Safety surveillanceRegulatory responseInvestigator BrochureProtocol developmentProject managementMedical WritingDevelop training materials for call centers



MCPHS

• Higher Education

• Adjunct Faculty

  • Jul 2012 - Dec 2013



Patheon Inc.

• Marketing and Competitive Intelligence Intern

  • Mar 2010 - Jul 2012

  Utilize different drug database (MedTrack, EvaluatePharma, IMS) to collect pertinent information to build intelligence pharmaceutical database and to seek potential partnering and acquisition opportunitiesOrganize IMS data to forecast sales of certain therapeutic areasProvide support such as gathering intelligence materials to other departments like Quotation and Finance Utilize different drug database (MedTrack, EvaluatePharma, IMS) to collect pertinent information to build intelligence pharmaceutical database and to seek potential partnering and acquisition opportunitiesOrganize IMS data to forecast sales of certain therapeutic areasProvide support such as gathering intelligence materials to other departments like Quotation and Finance



UNC Hospitals

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Pharmacy Intern

  • Jun 2010 - May 2011

  Performed literature search using Pubmed and other drug information databases to collect pertinent primary articles for a specific medicationCritically evaluated research articles and synthesized comprehensive drug monographResponded to drug information request from other healthcare providers within the hospital Performed literature search using Pubmed and other drug information databases to collect pertinent primary articles for a specific medicationCritically evaluated research articles and synthesized comprehensive drug monographResponded to drug information request from other healthcare providers within the hospital



Stanford

• Real Estate

• Research Assistant

  • Jan 2006 - May 2008