Job code: SPH-SC01-2018
Essential Duties And Responsibilities:
- Implementation, Upgrade and Maintenance of Drug Safety System(s).
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Running/Leading requirement gathering workshops, system demo and pilots.
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Business consulting and PV business process mapping.
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End user training.
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Subject matter expertise for Safety System setup (technical, configuration) and upgrades.
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Support during migration of drug safety data.
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Development and validation of standard and custom E2B solutions.
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Installation and upgrades of MedDRA and WHO drug dictionaries.
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Development and validation of advanced queries for data retrieval.
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Support during audits and inspections for assigned projects.
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Collaborate with Sophos’ quality team to assist in the creation of work instructions, policies and corrective/preventive action plans as needed.
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Guide and mentor direct reports in providing best in class support to client and internal projects.
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Ensure compliance with Sophos and client’s (as applicable) Standard Operating Procedures, policies and guidelines.
Minimum Education Qualification, Specialized Knowledge and Skills:
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BS degree or equivalent or higher.
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Minimum 5 years of professional experience in Drug Safety System implementation and configuration.
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In-depth experience of configuration and setup of Interchange, ESM, E2B (R2 and R3) and Admin(Console) configuration for Drug Safety System.
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Working knowledge of pharmacovigilance operations including, but not limited to case processing, expedited reporting, aggregate report preparation, signal detection, etc.
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Working knowledge of SQL and/or PL/SQL.
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Good understanding of Drug Safety (PV) domain.
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In-depth experience of working in a regulated space (pharmaceutical industry, particularly pharmacovigilance).
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Good understanding of applicable global and regional regulatory requirements (FDA, EMA) and ICH guidelines.
Primary Work Location
United States
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