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Safety Data Specialist
hace 3 meses
The Safety Data Specialist (SDS) is responsible for processing adverse experience (AE) information in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SDS should understand the importance of high quality and compliant AE case management. The SDS should also have a clear perception of case management processes, adhere to corporate policies and follow the company's Ways of Working, including leadership behaviors.
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Responsibilities and Primary Activities (may include but are not limited to)
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Process AE reports and meet Key Performance Indicators (KPIs).
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Index AE documents pushed from Central Receiving Mailboxes to the Indexing tool with required attributes.
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Provide medical translation service to meet the country regulatory requirement.
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Clarify discrepancies in the incoming information to achieve case consistency or accuracy.
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Complete training and independence assessment activities for GPVCM specialists.
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Education and other Qualifications
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Bachelor's degree or above in Health Care or job-related disciplines.
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Advanced writing/reading of medical content and intermediate speaking/listening English language skills.
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Basic IT skills (Outlook, Excel, browsing tools).
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Levels required for Core Competencies
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Data Analysis, Interpretation & Communication: Demonstrate familiarity and self-management based on analytical skills and detail orientation to achieve main business objectives.
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Competitive Decision Making & Execution: Utilize appropriate resources to make accurate and timely decisions that will impact positively own and others' work.
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Collaboration & Partnering: Have a common sense of joint responsibility and collaboration by demonstrating willingness and interest to gain new knowledge that can positively impact the day-to-day business.
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Disease Area Knowledge (Sub Competencies): Utilize medical/clinical knowledge to quickly adjust to new core responsibilities.
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Search Firm Representatives Please Read Carefully
Employee Status
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Regular
Relocation
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VISA Sponsorship
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Travel Requirements
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Flexible Work Arrangements
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Not Applicable
Shift
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Valid Driving License
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Hazardous Material(s)
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Requisition ID
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R285955
