Pharmacovigilance Safety Systems Analyst - United States
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This position is responsible for providing Argus-based systems support for Incyte Pharmacovigilance (Pharmacovigilance) activities, including technical and programming support, interacting with Incyte?s end users on technical matters, facilitation of user requirements gathering, implementation of user requirements and acts as a technical expert for designing customized/complex database solutions, queries and reports. This person supports the Pharmacovigilance team on safety systems related functions, including troubleshooting issues and liaising with appropriate partners to facilitate issue tracking and resolution.
- Contribute to the maintenance and management of the Pharmacovigilance safety system(s). This includes all the necessary configurations such as, user configuration, workflows, products & licenses, expediting rules, E2B reporting, etc.
- Assist with configuration and validation of safety system updates and upgrades, including but not limited to the development and execution of test scripts to verify compliance to system configuration.
- Perform the duties of an Administrator within the safety system.
- Identify, collate, and respond to issues raised concerning the Incyte safety system(s).
- Assist, develop, and perform data retrievals for all other Pharmacovigilance needs, e.g. compliance analyses and metrics, review of safety profiles of Incyte products.
- Day-to-day Pharmacovigilance safety system support to ensure continuity of reporting. Support submission activities associated with expedited individual case safety reports (ICSRs) to Regulatory Authorities and distribution of ICSRs to business partners, as needed.
- Contribute to the maintenance of all other systems in Pharmacovigilance, including but not limited to signal detection system (e.g., reporting systems, MedDRA upgrades).
- Assist in the generation of complete and accurate periodic regulatory reports and ad-hoc reports, for various constituencies with an interest in the safety database, e.g., Operations, Clinical, and Safety Review Team.
- Perform testing, validation and execution of E2B certification with partners and regulatory authorities.
- Assist in the creation / maintenance/ or delivery of training on Pharmacovigilance-specific procedural documents referring to the use of Incyte Safety Systems.
- Participates in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry.
- Provides safety user support and system administration. Assists with the development of safety system training materials and delivers training to employees with user training, as requested.
- Lead or support data migration activities and integration of systems with Pharmacovigilance system
- Minimum of 5 to 7 years of progressive experience in Systems Management or Safety Data Management (Argus experience required).
- Bachelor's degree in computer science, bioinformatics or related field required.
- Prior experience in the pharmaceutical or biotechnology industries is required.
- Experience with electronic submissions of safety data to regulatory authorities preferred.
- Experience in working on IT projects, GXP and validation requirements including documentation in a regulatory environment.
- Strong knowledge of pharmacovigilance terminology and system data entry conventions.
- Demonstrated technical, analytical and problem solving skills as they pertain to safety database systems preferred.
- Must be proficient in MS Office Suite.
- Broad knowledge of Pharmacovigilance Databases (e.g. Argus, ARISg).
- Programming experience with SQL or sufficient demonstrated proficiency required.
- Experience with E2B software (e.g., Axway) preferred.
- Familiarity with reporting tools such as Spotfire, Cognos or Business Objects preferred.
- Prior Experience in Business Configuration in Argus preferred.
- Prior experience in creating custom database queries preferred.
- Excellent written and verbal communication skills.
- Must demonstrate a keen attention to detail and timelines.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Ability to work both independently and in a collaborative team setting.
- Ability to interpret and follow regulatory guidelines
- Demonstrated leadership and project management skills.
- Ability to communicate across all levels of the organization.
- Excellent time management skills and a proven ability to work on multiple projects at any given time.
- Demonstrated ability to lead the analysis and resolution of complex problems.