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Drug Safety Database Manager

Key Responsibilities​

  • Ensure performance of day-to-day activities related to safety applications and programs necessary to maintain integrity of the Drug Safety process and system.
  • Oversee configuration of the Safety Database for products, studies, user privileges and workflow.
  • Perform programming, validation and configuration necessary to support data migrations, software upgrades, patches and data analysis to meet business requirements.
  • Lead the design, integration, implementation, and support of software applications as required, to meet Drug Safety needs and objectives.
  • Perform impact analysis of software upgrades and/or regulatory changes and effectively communicate potential impact affecting company initiatives.
  • Support retrieval of data from the safety database by providing ad-hoc reports for management, committee reviews, and ensure outputs meet global regulatory requirements as needed.
  • Maintain and manage E2B transmission and troubleshoot error messages to resolution.
  • Monitor performance of scheduled reports.
  • Document any safety system deviations and generate CAPAs as required.
  • Assist with preparation, review, and documentation of Drug Safety SOPs and guidelines related to safety systems and safety data management.
  • Perform training related to safety systems.
  • Support version management of dictionaries such as MedDRA and WHO Drug as required
  • Liaise with other functions, groups and organizations as needed to execute updates and patches to the system to meet departmental and corporate commitments.
  • Support compliance and regulatory inspection activity and/or audits by providing technical support as needed.
  • Perform oversight of third parties involved with management of safety database to ensure quality and timely end user support.
  • Develop change control test scripts and oversee script execution.
  • Ensure maintenance of database qualifications, security, compliance, licensing and coordinate disaster recovery and business continuity testing.

Requirements​

  • Experience with Oracle applications, especially Argus Safety and associated applications.
  • Experience developing scripts using PL/SQL programing; Knowledge of PHP and ASP is a plus
  • Experience establishing, maintaining and supporting electronic transmission between databases (e.g. E2B Gateway) required.
  • Understanding of EMA and FDA regulations with respect to clinical trials and post marketing reporting requirements
  • Understanding of regulations pertaining to electronic transmission of individual and aggregate safety reports
  • Understanding of ICH guidelines relevant to safety/pharmacovigilance, quality systems, GCP and GxP documentation
  • Basic understanding of MedDRA and Drug dictionary structures
  • Basic understanding of Cloud and Web technology
  • High level of proficiency with MS Office applications
  • Basic knowledge of scientific terms and medical terminology
  • Excellent interpersonal and project management skills.
  • Excellent prioritization skills and strong analytical/problem solving skills.
  • BS degree in in information technology or related technical field required; MS degree preferred.
  • Minimum of 8 years of relevant experience, which includes a minimum of 2 years of direct technical support of Argus safety system or other validated drug safety/PV systems.

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Drug Safety Database Manager