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Jobs · Information Technology · Georgia

Specialist/SR Specialist, PV Sys & Data Analysis

Boehringer Ingelheim · Johns Creek, GA · 1 wk ago
Information TechnologyFull-time

About the role

Execute activities associated with the Global Pharmacovigilance (PV) processes for PV Computerized Systems Administration and Data Analysis. Monitor these processes to ensure continued compliance with all BIV PV SOPs and competent health authority regulations. Identify areas which require change to maintain compliance and develop solutions. Act as a Subject Matter Expert for PV Systems, database administration, computerized system validation, and data retrieval. Manage projects under the direction of the Principal Specialist and/or PV Systems and Data Analysis Manager. Serve as a resource to support PV (global and local).

Responsibilities

  • Implement PV Systems Change Controls.
  • Provide guidance and support for PV Systems Administration for all environments (dev, val, prod, train).
  • Guide and train users with system use and data retrieval needs.
  • Lead the Change Advisory Board.
  • Investigate and resolve Level 2 system issues.
  • Ensure the system remains compliant with corporate procedures and multiple regulatory authorities’ requirements.
  • Develop new report queries/formats and execute routine reports.
  • Support PV System projects under the direction of the Principal Specialist and/or PV Systems and Data Analysis Manager.
  • Responsible for advanced system administration activities; escalate to Principal Specialist or Manager of PV Systems if configuration changes are needed.
  • Ensure compliance requirements are met for different regulatory authorities worldwide with varying requirements.

Requirements

  • Bachelor’s degree (e.g., Biology, Statistics, IS/IT) from an accredited institution.
  • Minimum of two (2) years of experience or five (5) years of experience working within a GMP/Compliance environment with a focus on data analysis.
  • Advanced degree (e.g., MSc, MBA) preferred.
  • Experience working with PVWorks, Trackwise, or similar validated databases.
  • Experience working with databases and database system support.
  • Regulatory and/or Compliance experience.
  • Demonstrated experience using SQL and SQL Software tools, Qlikview and/or statistical software tools, and Crystal Reports.
  • Working knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines.

Skills

  • Ability to remain calm under pressure and work to meet strict regulatory and customer-driven timelines.
  • Problem-solving skills including prioritization, innovation, and creativity.
  • Managing information from multiple sources, both internal and external.
  • Proficiency with Microsoft Office products, specifically advanced graphing in Excel.
  • Experience with computer systems validation deliverables and change control documentation.
  • Excellent oral and written communication skills.
  • Ability to operate effectively in a global and team environment and build consensus.
  • Attention to detail, quality-focused, and strong technical and problem-solving skills.
  • Excellent organization and time management skills.
  • Ability to manage conflict and provide solutions to balance business needs with user-friendliness.
  • Ability to think and work creatively and independently under pressure, demonstrating initiative and flexibility.
  • Fluent in spoken and written English.

About the Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow.

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