Ivan Gonzalez

Experience

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  Manpower

  Jan 2001 - Jan 2002

  Communications Assistant

  Interacted in coordinating and creating the Pfizer Groton/New London Site Operation’s 2002 Year Beginning Meeting.

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  Aerotek

  Jan 2002 - Jan 2003

  Contract Administrator

  Reissued and created new Master Service Agreements to more efficiently begin various Pfizer Phase I, II, III and IV Studies. Created confidentiality agreements for Pfizer consultants

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  Saybrook Associates

  Jan 2002 - Jan 2002

  Web Content Administrator

  Maintained the design and editing of the Pfizer Groton/New London Engineering and Small Projects Group Web Page.

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  Pfizer

  Jan 2004 - now

  Submission Tables Aggregate Report Lead for Cardiovascular, Consumer Health, Neuroscience, and Oncology Therapeutic Areas. SME (Subject Matter Expert) for areas of PBRER/ACO Quality Control Review, French Abuse Listing, IND AR Dataset for Oncology Products, and Clinical Registry. Vendor management oversight, overseeing generation of clinical trial and safety data tables related to submissions to worldwide regulatory agencies. Submission Tables Aggregate Report Lead for Cardiovascular, Consumer Health, Neuroscience, and Oncology Therapeutic Areas. SME (Subject Matter Expert) for areas of PBRER/ACO Quality Control Review, French Abuse Listing, IND AR Dataset for Oncology Products, and Clinical Registry. Vendor management oversight, overseeing generation of clinical trial and safety data tables related to submissions to worldwide regulatory agencies. Using Business Objects, generated clinical trial and safety data tables related to submissions to worldwide regulatory agencies. Contributions include Safety Updates, NDA PR, Investigator Brochures, IND Annual Reports, Canadian Annual Report, DSUR, ACO, PSUR and PBRER. Performed & recorded physical measurements including vital signs, body measurement & electrocardiograms. Recorded volunteer adverse events with referral to medical personnel for evaluation & treatment. Sample management collection & processing of biological samples. Worked in recruitment for study volunteers. Participated in a three person team to identify two Investigational Review Boards that the Clinical Research Unit could work with to meet the needs of the diverse New Haven community.

  • Aggregate Report Lead (Senior Manager)

    Dec 2019 - now

  • Aggregate Report Lead (Manager)

    Jan 2012 - Dec 2019

  • Submission Tables Specialist

    Jan 2007 - Jan 2012

  • Research Technician

    Jan 2004 - Jan 2007