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Bengaluru

    Advisor/Senior Advisor-Medical Review - Bengaluru, India - Lilly

    Lilly
    Lilly Bengaluru, India

    3 weeks ago

    Default job background
    Full time
    Description

    We're looking for people who are determined to make life better for people around the world.

    Key Responsibilities for Global Patient Safety (GPS) Medical Review

    1.Medical support of individual case adverse event and product complaint reporting process

  • Provide the medical and clinical expertise necessary to support case managers and call center staff involved in receiving, preparing and reporting adverse events and product complaints
  • Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in ensuring appropriate follow-up, reviewing assessments providing review for the medical content of Individual Case Safety Reports (ICSRs) as needed
  • To successfully meet these requirements, the Global medical reviewer associate medical advisor will work closely with the GPS Medical - therapeutic area and early phase medicine group physicians and Clinical Research Scientists (CRSs) and Safety Surveillance Teams (SSTs) to ensure appropriate communication of safety issues (both locally and globally), the medical quality of ICSRs and participation in the global assessment of the benefit: risk balance of Lilly products
  • Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety
  • Assist in supporting customer response activities associated with adverse events/product complaints
  • Provide review of the medical content of ICSRs that require medical review including the determination of the sponsor's assessment of relatedness for ICSRs that require this assessment.

    • 2.Regional GPS Medical Leadership

  • As a medical representative of GPS for spontaneously reported and clinical trial individual case safety reporting in the Americas Regional Center, contribute to the global assessment of safety of Lilly products and molecules in clinical trials by interacting directly with the GPS Medical - therapeutic area and early phase medicine group physicians and CRSs; and SSTs involved in assessing the safety profile of Lilly products. This responsibility requires regular participation (in person or by teleconference) in relevant GPS global scientific and surveillance meetings related to management of marketed product and developmental product safety.
  • Assist safety surveillance teams in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials suggesting a safety signal to the attention of SSTs, understanding Case Management specific issues and regulatory constraints, and conveying to the remainder of the Global Medical Review Group compound or trial specific issues and concerns.
  • Build collaborative working relationships with other Physicians and Scientists in GPS Medical as well as Development and Brand Teams globally to ensure full cooperation and high quality medical evaluation of safety data for Global Regulatory purposes
  • Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support, and similar activities in response to a changing regulatory environment or corporate priorities.
  • Act as the Lilly GPS Medical representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies
  • Build strong relationships with key customers, representing and championing the role of safety in the organization

    • 3.Understanding and support of the QPPV role

  • Have an understanding of the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV)
  • Ensure support is provided to enable the QPPV to fulfill the QP legal responsibilities

    • 4.Other job expectations

  • Maintenance of medical expertise in areas of interest or specialty is expected.
  • Understand and comply with all compliance policies, laws, regulations, the Red Book and the Corporate Integrity Agreement.
  • Understand the confidential nature of company information and take necessary steps to ensure its protection.
  • Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.

    • Minimum requirements:

    i) Bachelor's/Master's medical degree (MBBS/MD) from reputed institution.

    ii) Good clinical experience of handling patients is preferred.

    iii) At least 3-5 years of pharmaceutical industry experience, preferably in pharmacovigilance (medical review of individual case safety reports and related activities)

    iv) Strong written, spoken, and presentation communication skills

    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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