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    Medical Safety Lead

    Novartis
    4 years years
    Preffered by Company
    Not Disclosed July 9, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Medical Safety Lead

    Job ID: REQ-10013633
    Posted On: July 3, 2024
    Location: India

    Summary

    The Medical Safety Lead collaborates closely with the Global Program Safety Lead (GPSL) to provide robust safety evaluation expertise and medical innovation, aimed at improving patients' lives and impacting Novartis's overall results. As a member of the Medical Safety organization, the Medical Safety Lead prioritizes patient safety, ensures optimal safety for assigned compounds, and shares responsibility for the integration, analysis, and evaluation of internal and external safety information throughout the product lifecycle.

    Major Accountabilities

    • Clinical Safety Monitoring: Monitor the clinical safety of projects/products through activities such as literature review, evaluation of individual cases, signal detection, and appropriate responses to safety-related questions.
    • Medical Assessment: Perform medical assessments and related activities for single cases as required, including collecting follow-up information, evaluating product quality defects with adverse events, reviewing line listings of single cases, and preparing investigator notifications and periodic medical assessments for ethics committees.
    • Safety Signal Identification: Identify safety signals based on the review of solicited or unsolicited single cases, perform signal detection, monitoring, and evaluation of safety signals using proper tools.
    • Regulatory and Healthcare Inquiries: Provide inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues, prepare safety data for Health Authority review boards, and provide inputs to responses for legal queries and Country Organization requests involving safety issues.
    • Submission Support: Support the GPSL and Senior Medical Safety Lead in submission activities, providing pharmacovigilance inputs to the development and updates of core data sheets (CDS) and related documents.
    • Medical Input Preparation: Prepare medical input for aggregate clinical safety regulatory reports and collaborate on the preparation of Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates.
    • Guidance and Evaluation: Provide guidance to Clinical and Pharmacovigilance Operations for coding and causality/expectedness assessment of adverse event reports, and expert evaluation on the clinical context of adverse event reports.
    • Cross-Functional Collaboration: Collaborate productively with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments.
    • Safety Inputs: Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, reports, and investigator brochures. Support Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed. Support licensing activities, regulatory authority inspections, and project/product recall activities.

    Minimum Requirements

    • Education: Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in a relevant field, or Medical Degree (MBBS or MD). A medical degree with specialization is preferred.
    • Experience: At least 4 years in drug development within a major pharmaceutical company, including 2 years in patient safety in an operational or medical position (or equivalent experience).
    • Skills:
      • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing publications.
      • Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
      • Experience in preparing or contributing to clinical safety assessments and regulatory reports involving safety information.
      • Experience with issue management (safety or other).

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