job title: Analyst 2, safety systems(Baxter)

Roles and Responsibilities

• This position is for a member of the Global Patient Safety (GPS) – Technology team and responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking. Safety Systems Analyst I is a technical expert for managing system requests and updates to codelists and libraries. Also, the Analyst should also be able to provide oversight to Analysts (Systems and Data), support or perform training, coordinate with other team members on day to day activities and also participate in special projects/upgrade related activities. This role is also responsible for designing accurate database queries, report templates and reports out of the pharmacovigilance database.

  Responsibilities

  Responsibilities include, but are not limited to the following:

  • Perform all tasks as needed by the Safety Systems analyst I & II role

  • Support maintenance of current pharmacovigilance safety system (ARGUS) and other GPS systems

  • Ability to work flexible hours supporting users in different time zones. May need to work in shifts as needed/assigned.

  • Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine changes and Change Requests).

  • Participate and lead Systems support tasks and projects providing technical expertise on PV database (ARISg/ARGUS)

  • Good Knowledge of E2B profile logics, customizations

  • Ability to develop Database queries, customize and automate activities

  • Participate and lead activities related to data management, periodic and ad-hoc reports as needed

  • Initiation, review and notification of routine changes to pharmacovigilance safety system.

  • Review and analysis of user requirements prior to submission and implementation, participate in validation activities as required.

  • Train other team members on systems configurations, business administration and other database related activities

  • Monitor / Perform periodic review of administrator data including but not limited to user access, company product dictionary and Safety Data Exchange agreements.

  • Ensure that changes made to the databases are controlled through the change control process.

  • Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional area prior to processing for implementation

  • Responsible for creating, verifying and tracking complex change requests, including updates to reporting rules, product lists and code lists.

  • Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changes

  • Partner in the development of system-related training programs and deliver training as needed

  • Maintain and manage SharePoint sites used for tracking systems requests (Routine changes and Change Requests)

  • Take initiative to recognize, prioritize & escalate potential safety/ compliance issues

  • Train and develop other team members in area of Systems support and database configuration

  Qualifications:

  • Excellent technical, analytical and problem solving skills as it pertains to Pharmacovigilance database systems

  • Strong knowledge of Pharmacovigilance system (e.g. ARISg, ARGUS) with good understanding of the database structure and application architecture

  • Strong technical system skills (e.g. Word processing, Excel spreadsheets, Powerpoint, Sharepoint, SQL and Databases)

  • Strong knowledge of pharmacovigilance terminology and understanding of data entry conventions

  • Excellent oral and written communication skills with attention to detail

  • Excellent interpersonal skills that encourage teamwork

  • Ability to work independently under strict deadlines and changing priorities

  • Ability to multitask and prioritize changing workload for self and others on daily basis

  • Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU Regulations

  • Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance

  • Provide guidance to team members in area of routine system maintenance, data management, reports generation and tasks related to special projects/upgrades

  Education / Experience:

  • Bachelor's degree or higher degree in computer science, life sciences or equivalent

  • Experience as both an individual contributor and as a participant/leader in a team environment

  • Minimum of 2 years of previous experience in Pharmacovigilance Systems Management or Data Management or related area