Grace Burch

Experience

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  IQVIA (formerly Quintiles)

  Oct 2007 - Sept 2010

  Pharmacovigilance/ Life cycle Specialist

  Global PV/safety lead of various clinical trialsInvolved in project set up, writing project safety plans, attending and presenting at Investigator and CRA meetings, budget planning and review, metrics preparation, SAE collation, processing, evaluation and QC, HA/EC/Investigator submission of SUSARs and aggregate reports, query writing, participating in Audits etc.

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  Bristol-Myers Squibb

  Jul 2015 - Apr 2017

  PV associate for the Asia Pacific region.Involved mainly in post marketing and early access programme PV activities e.g. AE entry of cases from various sources. Sending queries to HCP's. Reconciliation with vendors/ medical information etc. Regular review of Asia Pac country reporting requirements, Case assessment for reportability and submission to HA's. Submission of required aggregate reports to HA's/EC's/ investigator's. Review patient access program/ expanded access program/ market research matierials for PV input. Liase with business partners with regards to co-marketed/co-promoted products. Provide PV training to vendors/ sales reps/ other employees who have contact with HCP's. Show less

  • Senior Pharmacovigilance Associate

    Feb 2011 - Apr 2017

  • Clinical Site Monitor ( 6mth Work rotation)

    Jul 2015 - Jan 2016
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  Novartis

  Jun 2017 - Feb 2018

  Quality Assurance Development Associate (Mat leave contract)

  Clinical trial Quality Assurance (performing remote and onsite clinical audits and in house audits checking for compliance to ICH GCP, Protocols, regional regulations etc)

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  Cancer Trials Ireland

  Feb 2018 - now

  Pharmacovigilance Manager

  Responsible for all Pharmacovigilance/safety activities in the organisation from budgeting and reviewing protocols in first study proposal, to study set up, writing safety sections of protocols, creating safety databases and aligning with CRF, processing all SAEs, SUSARs, creation and submission of DSURs, reconciliation, creation and maintenance of all PV SOPs, maintaining awareness of all regulations in countries of study participation, present data for all safety meetings (e.g. Medical Oversight meetings with Clinical lead, Safety Monitoring Committees). Line manage and mentor PV staff. Show less