Associate/Sr. Associate Manager Safety Data Sciences

1-8 years

Not Disclosed

India

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Job Title: GPS Systems and Reporting Specialist

Location: Eli Lilly Capability Center, Bengaluru, India
Company: Eli Lilly and Company

About Us:

At Eli Lilly, our mission is to combine compassion with innovation to enhance lives worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, we are dedicated to discovering and delivering life-changing medicines, improving disease management, and contributing to our communities through philanthropy and volunteer work. We are seeking passionate individuals who are committed to making a positive impact on global health.

Role Overview:

The GPS Systems and Reporting Specialist is responsible for the development, maintenance, and optimization of GPS systems used in safety reporting and operational processes. This role involves system development, safety reporting, operational excellence, and ensuring compliance with regulations and standards. You will work closely with various teams to support GPS functions, drive improvements, and ensure the accurate and timely delivery of data and reports.

Primary Responsibilities:

System Development & Maintenance (40%)
- Support and develop new or existing GPS systems, tools, and technologies.
- Utilize standard validation principles and methodologies to maintain and enhance GPS applications.
- Influence and drive change management for GPS systems.
- Manage data migration and transfer processes related to GPS data.
- Configure GPS safety systems and conduct Product License Study (PLS) activities.
- Serve as a Subject Matter Expert (SME) for GPS system configuration activities.
Safety Reporting (30%)
- Create and manage existing and ad-hoc queries and visualizations to support GPS and Lilly safety reporting needs.
- Ensure the accuracy and validity of reports by understanding GPS systems data.
- Maintain high-quality output through rigorous review and validation.
Operational Excellence (20%)
- Provide support to GPS functional areas and therapeutic teams, ensuring consistency and identifying process improvements.
- Communicate proactively with stakeholders, including customers, vendors, and IT groups, to align on reporting requirements.
- Develop self-service and enhanced reporting options for GPS/Lilly functional areas.
- Leverage performance data to drive capability improvements and strategic direction.
- Engage in benchmarking to identify automation and technology enhancement opportunities.
Compliance (10%)
- Generate validated reports for audits and inspections.
- Maintain accuracy and performance of routine reports; prepare records for summaries and ad-hoc reports.
- Ensure compliance with regulations and guidelines, and safeguard confidential company information.
- Support the EU Qualified Person (QP) in fulfilling legal responsibilities.

Minimum Qualifications:

Master’s/Bachelor’s degree in health science, Mathematics, Statistics, Computer Science, or a related field, or equivalent experience.
Proven experience with data, reporting, and systems/processes.

Additional Preferences:

Experience in the pharmaceutical industry, with a strong understanding of pharmacovigilance or clinical research.
Knowledge of GPS safety systems and business processes.
Experience working in a highly regulated environment.
Familiarity with Computer System Quality (CSQ) requirements.
Proficiency in data analysis and visualization tools (e.g., Excel, Business Objects, Power BI).
Experience with Microsoft tools (e.g., SharePoint, MS Flows).
Ability to work effectively in a virtual team environment.
Strong interpersonal, leadership, and communication skills.
Expertise in process management, critical thinking, attention to detail, and the ability to meet deadlines.

Additional Information:

Eli Lilly and Company is committed to ensuring equal employment opportunities and supporting individuals with disabilities in the workforce. If you need accommodations to apply for a position at Lilly, please contact Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com. This email is intended only for accommodation requests related to the application process.

Lilly is an equal opportunity employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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Associate/Sr. Associate Manager Safety Data Sciences

Job Description

Job Title: GPS Systems and Reporting Specialist

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