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Administracja biurowa » Pracownik biurowy

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UBC - Associate Director, Pharmacovigilance Nr ref.: /JOBS.pl Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.Brief Description:The Associate Director, Safety oversees the conduct of the Safety Department and assist the Executive Director/Director, Safety in his/her task. Responsible for guiding proposals, processes, budgets, regulations and staff in order to ensure quality deliverables. Specific Job Duties:Evaluate and respond to client requests for proposal as requestedParticipate in bid-defense preparation and presentationEvaluate and determine appropriate Safety resources to assign to project teams as requested for study proposals and study executionEvaluate staffing requirements and adjust accordinglyEvaluate the program specific requirements and document the required proceduresOperationalize the safety aspects of the protocol and/or programOversee safety staff and processes Evaluate safety project budgets and participate in Change Order generationOversee reporting timelines and evaluate complianceMentor safety staff on regulations, processes, client interactions and other areas as neededStay abreast of regulatory updates and train staff on new regulations and guidelinesWork with Executive Director/Director Safety, Executive Director-Clinical Operations, Director IT and Data Management, Director - Regulatory Compliance, Project Directors, Director - Late Stage Programs, Project Managers, CRA I Manager, CRA II Manager, Epidemiology and Risk Management staff, Controller and other assigned staff to continually update project systems, standard operating procedures, adverse event reporting plans, group-wide training programs, study specific plans and to review project specific processes and ensure acceptance of Pharmacovigilance processes into the UBC Standard Operating ProceduresAttend client operational Face to Face meetings, Investigator meetings and teleconferences Generate and Monitor Department MetricsAttend, participate and lead monthly/quarterly Managers-Directors MeetingsConduct annual employee performance evaluationsPrepare procedures, SOPs, guidelines and other standard materials required for departmental functionWork directly with Human Resources for the ongoing recruitment of resources that are in the Corporate Approved Group Budget Supervisory Responsibilities:Supervision of Safety staff Requirements:Bachelor's Degree is required- preferably in HealthCare discipline, advances degree is preferredMinimum 5 years of experience at increasing levels in Pharmacovigilance with responsibilities including prior responsibilities at the departmental levelGlobal Pharmacovigilance experience preferredComprehensive knowledge of ICH and FDA regulations and guidelines both clinical and post marketingExperienced in management of multiple Safety staff with department management experience preferredExcellent written and verbal communication skillsFluent in English, additional language fluency a plus, but not requiredProficient with computer programs (Safety database, WORD, PowerPoint, excel, Visio, MS Project)*LI-AF1-UBCNO AGENCIES PLEASE Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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