Andrew Faircloth

About Andrew Faircloth

Mr. Andrew Faircloth is a Manager of Reporting and Submissions in the Global Safety and…

Experience

1. Manager, Reporting & Submissions

   Biogen

   Jan 2016 — Present · Cambridge, MA, US

   Promoted: Manager, R&S, Jun 2019-PresentPromoted & hired permanently: R&S Senior Associate II, Jul 2016-Jun 2019R & S Senior Associate I (contract, Syneos Health), Jan 2016-Jul 2016Workflow management: Pending submissions & daily compliance risk oversight.Vendor Management: oversight of interventional clinical trial submissions vendor.Reports:Create & QC aggregate listings & ASRs/DSURs.Produce PSUR/PBRER schedule & perform associated data edit checks.Create & run reconciliation reports with SDEA/PVA partners.Submissions:Subject Matter Expert (SME) on automated global safety database (GSD) distribution rules created with SQL. Monitor, investigate, resolve & re-submit E2B failures.Set-up & test submission gateways.Soft delete & nullify cases in the GSD.Submit literature articles via FDA WebTrader.Update GSD to reflect IND, CTA & MAA approvals. Review clinical trial protocols, international regulatory intelligence, and SDEAs/PVAs for GSD distribution rule alignment.Create & submit Power of Attorney & Delegation of Authority letters.

Education

• East Carolina University

  Bachelor of Science - BS, Clinical Laboratory Science

Skills

• Clinical Monitoring
• Clinical Research
• Ich-Gcp
• CRO
• Meddra
• U.s. Food and Drug Administration (Fda)
• Regulatory Affairs
• Clinical Development
• Edc
• Therapeutic Areas
• Ctms
• Gcp
• Pharmaceutical Industry
• Sop
• Drug Safety
• Good Clinical Practice (Gcp)
• Pharmacovigilance
• Clinical Trials