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    Officer- Literature Screening

    Lambda Therapeutic Research
    0-2 years
    Not Disclosed
    Ahmedabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Officer - Literature Screening
    Company: Lambda Therapeutic Research Ltd.
    Location: Ahmedabad, India
    Date: December 26, 2024

    Organisational Overview

    Lambda Therapeutic Research Ltd. provides comprehensive pharmacovigilance services for a wide range of products, including generics, combination products, vaccines, and medical devices. With a global team of over 160 professionals, Lambda supports drug safety monitoring for clinical trials across various therapeutic areas. Their expertise ensures compliance with regulatory standards throughout the lifecycle of medicinal products, utilizing advanced technology and automated, web-based solutions for streamlined processes and data handling.

    Job Description

    Lambda Therapeutic Research Ltd. is seeking an Officer - Literature Screening to join its pharmacovigilance team. This role is responsible for reviewing global scientific and medical literature, maintaining organized records, preparing and revising standard operating procedures (SOPs), and supporting case processing activities such as data entry and coding. The Officer will work with a global team to ensure accurate safety monitoring and compliance with regulatory requirements.

    Key Responsibilities

    • Literature Review:
      • Review global scientific and medical literature per company SOPs, WIs, and relevant regulations.
      • Maintain organized records of all literature safety reports received and reported.
    • Safety Case Processing:
      • Support case processing activities, including data entry, drug coding, MedDRA coding, listedness assessment, expediting assessment, and narrative writing.
      • Enter literature cases from PubMed and initiate cases in the safety database.
    • SOPs and Documentation:
      • Prepare, revise, and review SOPs, WIs, templates, guides, and training documents.
    • Case Tracking and Communication:
      • Track all cases received from regulatory authorities and reconcile them weekly with their sources.
      • Communicate urgent safety issues to the Line Manager and Qualified Person for Pharmacovigilance (QPPV).
      • Ensure high standards in internal and external communications, maintaining accurate records.

    Key Deliverables

    • Review and process literature safety reports.
    • Timely and accurate documentation of pharmacovigilance activities.
    • Efficient management of case tracking and reconciliation.
    • Consistent communication of safety issues and updates to management.

    Experience

    • Preferred: Pharmacovigilance certification course.
    • Experience: Relevant experience in pharmacovigilance, especially related to literature screening, will be prioritized.

    Educational Qualification

    • Required: B. Pharm, M. Pharm, Pharm D (Preferably in Pharmacology).

    Competencies

    • Accountability: Take responsibility for quality assurance and safety case management.
    • Communication: Strong communication skills for both internal and external interactions.
    • Work Ethic: Commitment to maintaining high standards in all work aspects.
    • Initiative: Proactive approach in identifying and addressing issues.
    • Leadership: Ability to work collaboratively within teams.
    • Technical Knowledge: Familiarity with pharmacovigilance tools, regulatory requirements, and literature screening.
    • Academic Qualifications: Relevant qualifications in pharmacology or related fields.
    • Motivation/Initiative: Ability to drive tasks and manage deadlines efficiently.
    • Interpersonal Skills: Strong teamwork and interpersonal communication.
    • Flexibility/Planning & Organizing: Ability to prioritize and organize work efficiently.

    How to Apply

    Interested candidates are encouraged to apply through Lambda Therapeutic Research Ltd.'s official career portal.

    Let me know if you need further details or assistance!

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