- 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.
- 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.
Medical Director – Clincal Research and Development
Drug Safety Database Manager