at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Senior Safety Systems Analyst is responsible for providing Argus-based systems support for Incyte Pharmacovigilance (PhV) 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. The Senior Analyst supports the PhV team on safety systems related functions, including troubleshooting issues and liaising with appropriate partners to facilitate issue tracking and resolution.
Essential Functions of the Job (Key responsibilities)
Contribute to the maintenance and management of the PhV 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 PhV needs, e.g. compliance analyses and metrics, review of safety profiles of Incyte products.
Day-to-day PhV 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 PhV, including but not limited to signal detection system (e.g., Empirica), 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 PhV-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.
Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
Maintain files and systems as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in computer science, bioinformatics or related field required.
Minimum of 5 to 7 years of progressive experience in Systems Management or Safety Data Management (Argus experience 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, Empirica).
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 creating custom database queries preferred.
Must demonstrate a keen... For full info follow application link.
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