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    Associate/ Senior Associate - Safety Management

    Eli Lily
    Freshers years
    2-4 LPA
    Bangalore
    10 July 11, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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: Associate/Senior Associate - Safety Management

     

    Location

    • Bangalore, Karnataka, India

    Category

    • Research & Development

    Job Type

    • Full Time
    • Regular

    Job ID

    • R-59538

    About the Job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

     

    Primary Responsibilities

    • Adverse Event Management: Apply clinical judgement, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems, ensuring data integrity, consistency, and compliance.
    • Knowledge Expansion: Continuously expand knowledge of Lilly compounds/products, including clinical trials design, safety profiles, regulatory commitments, indications, identified risks, main adverse reactions, and risk minimization activities.
    • Regulatory Expertise: Expand expertise on case collection and expedited reporting requirements from major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
    • Team Participation: Participate as a cross-functional team member on assigned study teams.
    • System Functioning: Understand and contribute to the updates/enhancements and resolution of workflow issues in systems owned by GPS (e.g., MOSAIC, LSS).
    • Safety Information Processing: Process adverse events and other safety information from various sources, including clinical trials, patient support programs, Lilly market research, literature, and spontaneous reports.
    • Report Assessment: Assess individual reports to identify gaps in information and conduct follow-up to clarify seriousness, expectedness, causality, and achieve case completion.
    • Timeline Compliance: Comply with internal and external timelines for managing adverse event data entry.
    • Literature Search: Lead/support updates to literature search strategies and address system issues/enhancements.
    • Regulatory Translation: Translate global/regional/local pharmacovigilance regulatory requirements into expedited reporting rules and conduct product license studies activities.
    • Data Management: Ensure the completeness and accuracy of data management within GPS systems and associated case management activities.
    • Case Management: Manage adverse events from various sources, ensuring appropriate serious outcome criteria, term selection, listedness, relatedness, and availability for medical review.
    • MedDRA Coding: Complete or verify MedDRA coding.
    • Medication and History: Identify concomitant medication and relevant medical history.
    • Follow-Up Management: Ensure appropriate follow-up using a customer experience mindset with patients, HCPs, or investigators/site personnel.
    • Work Management: Proactively manage incoming work, prioritize, and collaborate with global colleagues to ensure timelines are met.
    • Project Participation: Provide expertise on local or global projects to ensure innovation and improvements in safety management.
    • PV Agreement Understanding: Maintain understanding of pharmacovigilance agreements for assigned products.

     

    Minimum Qualification Requirements

    • Education: Master’s degree or equivalent experience. Healthcare degree or study in pharmaceutical/biological sciences preferred.
    • Critical Thinking: Ability to solve problems and make decisions autonomously and as part of a team.
    • System Adaptability: Flexibility in using electronic systems and adapting to new and changing systems.
    • Computer Skills: Basic skills in word processing, tables and graphics, spreadsheets, presentations, templates, databases, and search engines.
    • Teamwork: Ability to work effectively in a global team and apply understanding of diversity and inclusion.
    • Language Proficiency: Fluency in English (written, read, spoken).

     

    Additional Information

    Eli Lilly and Company, Lilly USA, LLC, and our wholly owned subsidiaries are committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you require accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com for further assistance.

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

    #WeAreLilly

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