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Oversee the management of& nbsp; Pharmacovigilance processes and staff at UBC. Responsible for the planning and execution of the safety requirements in support of Clinical Trials and Spontaneous Adverse Event Reporting programs.& nbsp; & nbsp; & nbsp; & nbsp; & nbsp; Hire, train and supervise Safety Staff& nbsp; & nbsp; & nbsp; Prepare adverse event reporting plans (AERP)Receive telephone calls, faxes, e-mails, etc., from medical doctors, study coordinators, allied health personnel, patients, caregivers and other parties reporting potential adverse eventsPrepare draft MedWatch and CIOMS I formsEnter data into safety databaseCode safety data using MedDRA safety dictionaryCode medications using WHO-DrugCode medical history using ICD-9 Cm or other coding schemeAssist in preparation of annual IND safety updates and PSURS-assist in preparation of monthly adverse event reports for clientsAssist in reconciliation of clinical and safety databasesPrepare internal SOPs and Study Specific Procedures
Details :
- company: UBC
- employee_type: Part Time
- full_time: Full Time
- job_title: Safety Manager
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