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Associate/Sr. Associate Manager Safety Data Sciences

2+ years
Not Disclosed
10 Oct. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

GPS Systems Specialist

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader based in Indianapolis, Indiana, our mission is to develop life-changing medicines, enhance disease understanding, and give back to our communities. We prioritize our people and seek individuals committed to making a positive impact.

Job Description

Primary Responsibilities
This overview outlines the primary responsibilities of the GPS Systems Specialist role. Specific duties may evolve over time, and additional responsibilities may arise. Please consult with your supervisor for the latest updates.

  1. System Development & Maintenance (40%)

    • Support and develop new or existing GPS systems, tools, and technologies.

    • Utilize standard validation principles and methodologies for GPS-based applications.

    • Influence and manage the change process for GPS-owned systems.

    • Oversee data migration and transfer processes involving GPS data.

    • Configure GPS safety systems and conduct Product License Study (PLS) activities.

    • Serve as a Subject Matter Expert (SME) for GPS system configuration.

  2. Safety Reporting (30%)

    • Support GPS and Lilly safety reporting needs by creating queries and visualizations.

    • Ensure reports meet GPS/Lilly requirements through thorough understanding and validation of data.

    • Validate output for accuracy and compliance.

  3. Operational Excellence (20%)

    • Provide support to GPS functional areas and therapeutic teams.

    • Identify process gaps and improvement opportunities.

    • Communicate proactively with stakeholders on safety report requests and timelines.

    • Develop self-service reporting options for GPS/Lilly functions.

    • Engage in benchmarking to identify automation and technology improvement opportunities.

  4. Compliance (10%)

    • Produce standard or custom validated reports for audits and inspections.

    • Maintain accuracy and performance of routine reports and prepare summaries.

    • Ensure compliance with regulations and standards.

    • Support the EU Qualified Person (QP) in fulfilling legal responsibilities.

Minimum Qualification Requirements

  • Master's or Bachelor's degree in health sciences, Mathematics, Statistics, Computer Science, or a related field.

  • Experience with data, reporting, and processes/systems.

Other Information/Additional Preferences

  • Experience in the pharmaceutical industry or understanding of pharmacovigilance/clinical research.

  • Knowledge of GPS safety systems and business processes.

  • Familiarity with Computer System Quality (CSQ) requirements.

  • Proficiency in data analysis and visualization tools (e.g., Excel, Power BI).

  • Experience with Microsoft tools (e.g., SharePoint, MS Flows).

  • Strong interpersonal, leadership, and communication skills.

  • Excellent critical thinking and attention to detail.

  • Proven ability to meet deadlines and deliver results.

Lilly is committed to fostering an inclusive workplace. If you require assistance submitting your application due to a disability, please email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com for further assistance. This email is intended only for accommodation requests; other inquiries will not receive a response.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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