Ian Burnham Email & Phone Number

Welwyn Garden City, England, United Kingdom

Subject Matter Expert (SME) for:ICSR Follow-upEmergency Unblinding (SUSAR)Guided QuestionnairesSpecialist Pregnancy Follow-upManagement of the workflows, metrics, and CAPA's for ICSR's outsourced to CRO in respective disciplines.

Cambridge, United Kingdom

Management of the workflow of all ICSR's outsourced to CRO:• Manage the vendor and project, ensuring processes are being followed in the agreed timelines.• Regular communication with the CRO team, including hosting weekly teleconference meetings to ensure full oversight is maintained.• Timely communication to stakeholders regarding CRO activities and performance as appropriate• Identify process improvements and implement in a timely manner and SOP management• Ensure all procedural documentation supplied to the CRO is updated accordingly • Identify training requirements of the CRO team, and provide the training accordingly.• Review and provide feedback on quality of output. • Develop and maintain a strong and robust relationship with the CRO/vendor• Hands on Case processing and case assessment where required• Hands on Clinical Trial case processing and assessment where requiredResponsible for the process of reviewing all QC edits required on cases;• Responsible for the QC edit process for CRO cases• Review the current process, identifying/implementing improvements• Make and agree upon proposals for implementation• Define timelines and objectives• Provide feedback to CRO where appropriate• Implement and monitor KPIsResponsible for the report distribution and submission of all expeditable serious and non-serious cases completed by the CRO and worldwide Associated Companies.Provide face to face training to customer interacting staff in the UK regarding Adverse event reporting and their responsibilities. Produced the Company E-learning module on Adverse Event Reporting, made available to all company members, and now shared internationally, including Napp and Mundipharma Independent Associated companies.• Responsible for Regulatory Affairs Inbox and responding to queries• Actioning requests for database entries into Athena, the company Regulatory Management Database.• Problem solving relating to Regulatory Submissions

Cambridge, United Kingdom

Management of the workflow of all ICSR's outsourced to CRO;• Manage the project, ensuring processes are being followed in the agreed timelines.• Regular communication with the CRO team, including hosting weekly teleconference meetings to ensure full oversight is maintained.• Timely communication to manager and team regarding CRO activities and performance as appropriate• Identify process improvements and implement in a timely manner• Ensure all procedural documentation supplied to the CRO is updated accordingly • Identify training requirements of the CRO team, and provide the training accordingly.• Review and provide feedback on quality of output. Responsible for the process of reviewing all QC edits required on cases;• Responsible for the QC edit process for CRO cases• Review the current process, identifying/implementing improvements• Make and agree upon proposals for implementation• Define timelines and objectives• Provide feedback to CRO where appropriateResponsible for the report distribution and submission of all expeditable serious and non-serious cases completed by the CRO and worldwide Associated Companies.Provide face to face training to customer interacting staff in the UK regarding Adverse event reporting and their responsibilities. Produced the Company E-learning module on Adverse Event Reporting, made available to all company members, and now shared internationally, including Napp and Mundipharma Independent Associated companies.

Cambridge

Cambridge, United Kingdom

Supported three Marketing Managers during a major product launchManaged Multi Million Pound budgetLiaised with large Sales ForceComplex Diary ManagementTravel arrangementsConference set upManaging ABPI compliance issues for promotional materialsInterface between Medical Information, Drug Safety and MarketingMinute Taking

Cambridge, Uk

Responsible for Medical Information triageDistributing Medical Information correspondence and answering specific queriesLead for global journal subscriptions and company budgetSet up international online journal accessSingle point of contact to arrange all company translation requirementsResponsible for European copyright in relation to Regulatory Authority requirementsAssisted Medical Information Scientists with international call handlingAssisted with Literature searching and handling e.g. product specific articlesProducing and distributing monthly bulletins relating to company products and entitiesInvolved with Regulatory Audits e.g. MHRAResponsible for Reconciliation with Drug Safety and Complaint departmentsGap Analysis and SOP management

Cambridge, United Kingdom

Negotiating national contracts with large construction conglomerates. Fact finding, relationship building, passing on competitor intelligence.I also developed a strong relationship with the Ministry of Defence, and Home Office, during this period, and periodically spent periods of time assisting these government departments preparing plans, and sensitive tenders, as well as visiting various military installations to assess needs.

Grade 8, Pianoforte, 8

Creative Writing, 1

Activities and Societies: Tutoring with Malcolm Bradbury and other authors