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Job #03533

About our client Our Client is a well-established international research organization with its own oncology division. With its extensive background in clinical research and solid infrastructure (80 employees), our Client has the means to develop, manage and conduct a study in its entirety, ranging from a small phase I to large phase III trials. It is being recognized as one of the major networks in breast cancer clinical research with over 9,000 patients enrolled. Position Location Director of Drug Safety & Pharmacovigilance Alberta Salary Highly competitive package, commensurate with experience Responsibilities The Drug Safety & Pharmacovigilance (DS&P) Director is responsible for the medical, regulatory, and logistic management of the Serious Adverse Events (SAE) that occur in company trials. He/she interacts with other company teams (Project Management, Clinical Research Associates (CRAs) Management, Local CRAs, Data Management, Medical Director), the investigators, the sponsors and with the Independent Data Monitoring Committee in order to assure the safety of the patients involved in company trials. 1) Supervise the management of the SAE reports from a medical, regulatory and administrative standpoint. 2) Set up, implement and maintain an efficient SAE processing / dispatching logistics for the investigators, CRAs, sponsors and Health Authorities. 3) Provide adequate support to the Project Managers (Global Clinical Coordinators and Study Managers) and the CRAs to assure an appropriate monitoring and follow up of the SAE. 4) Implement and maintain an efficient collaboration and communication process with the Pharmacovigilance (PV) departments of the sponsors. 5) Write all appropriate Standard Operating Procedures (SOPs), guidelines and processes as needed. 6) Write the Pharmacovigilance report requested by the IDMC/DSMB. 7) Set-up, implements, and maintain an appropriate PV database in collaboration with the data management and Information Technology departments. 8) Contribute to the training of the different company teams involved in the clinical research as far as Clinical Safety and SAE Reporting are concerned. 9) Participate in the study budget elaboration. 10) Coordinate and identify manpower needs according to the number and the complexity of the ongoing and future projects. Requirements 1) Medical or Pharmaceutical background. (MD or PharmD) 2) At least 5 years of experience in Clinical development / project management and 2 years in Drug Safety and Pharmacovigilance. 3) Knowledge in oncology and experience in oncology trials are preferred. 4) Knowledge with AERS database is preferred. 5) Fluent English is required. 6) Written communication (e.g. safety reports, SOP) experience is required. Oral communication (training, presentation) experience is required. 7) Fluency in French would be an asset. 8) Management skills, sense of prioritization, coaching sense and communication easiness. Team spirit, organization and planning, oral and written communication, identification of problems and implementation of solutions, able to work in a multi-cultural environment, able to work in a rapid growing and evolving academic group, good informatics knowledge (Word, Excel, Power Point). 9) This position supervises a staff of eight administrative, junior and senior positions. This position reports to Chief Operations Officer.