Job code: SPH-SC01-2018

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Essential Duties And Responsibilities:​

  • Implementation, Upgrade and Maintenance of Drug Safety System(s).

  • Running/Leading requirement gathering workshops, system demo and pilots.

  • Business consulting and PV business process mapping.

  • End user training.

  • Subject matter expertise for Safety System setup (technical, configuration) and upgrades.

  • Support during migration of drug safety data.

  • Development and validation of standard and custom E2B solutions.

  • Installation and upgrades of MedDRA and WHO drug dictionaries.

  • Development and validation of advanced queries for data retrieval.

  • Support during audits and inspections for assigned projects.

  • Collaborate with Sophos’ quality team to assist in the creation of work instructions, policies and corrective/preventive action plans as needed.

  • Guide and mentor direct reports in providing best in class support to client and internal projects.

  • Ensure compliance with Sophos and client’s (as applicable) Standard Operating Procedures, policies and guidelines.

 

Minimum Education Qualification, Specialized Knowledge and Skills: ​

  • BS degree or equivalent or higher.

  • Minimum 5 years of professional experience in Drug Safety System implementation and configuration.

  • In-depth experience of configuration and setup of Interchange, ESM, E2B (R2 and R3) and Admin(Console) configuration for Drug Safety System.

  • Working knowledge of pharmacovigilance operations including, but not limited to case processing, expedited reporting, aggregate report preparation, signal detection, etc.

  • Working knowledge of SQL and/or PL/SQL.

  • Good understanding of Drug Safety (PV) domain.

  • In-depth experience of working in a regulated space (pharmaceutical industry, particularly pharmacovigilance).

  • Good understanding of applicable global and regional regulatory requirements (FDA, EMA) and ICH guidelines.

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Primary Work Location

United States

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