Job Detail

 

Summary

 

This position is responsible for providing Safety systems support for Incyte Pharmacovigilance including Argus and other technical based solutions. The position will be responsible for providing both technical and programming support, interacting with Incyte’s end users on technical matters 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.

 

Duties and Responsibilities

       

• 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.

 

• 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.   

  

Requirements 

• Bachelor's degree in computer science, bioinformatics or related field required.

 

• Minimum of 3 to 4 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.

  

• 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.

 

• Excellent verbal and written communication skills

 

• Must demonstrate a keen attention to detail and timelines.

 

• Ability to work both independently and in a collaborative team setting.

 

• Ability to interpret and follow regulatory guidelines.