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    Serm Scientific Director

    Gsk Plc
    6+ years
    Not Disclosed
    Bangalore
    10 Aug. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Opportunity at GSK: Medical/Scientific Expert in Pharmacovigilance

    Locations: Warsaw, Bangalore
    Posted Date: August 5, 2024

    Job Purpose

    As a Medical/Scientific Expert in Pharmacovigilance at GSK, you will provide in-depth expertise in safety evaluation and risk management for key GSK assets, both in clinical development and post-marketing settings. You will ensure the scientifically sound review and interpretation of data, manage safety issues, and escalate critical concerns to senior management as needed. Your role will involve recommending strategies for characterizing, managing, and communicating safety risks, focusing on efficiency and effectiveness to meet the needs of patients and healthcare professionals (HCPs).

    Key Responsibilities

    Scientific/Medical Knowledge and Expertise

    • Lead Pharmacovigilance and Risk Management Planning, developing strategies for evaluating issues within the clinical matrix.
    • Oversee the safety component of global regulatory submissions.
    • Apply expert evaluation skills and analytical thinking to literature reviews, clinical data synthesis, analysis, and interpretation.
    • Demonstrate quality decision-making and creative problem resolution based on comprehensive information and context.
    • Exhibit advanced multi-tasking abilities, prioritize tasks effectively, and consistently meet deadlines with high performance standards.
    • Explore and negotiate positions and alternatives to reach mutually beneficial solutions.

    Cross-functional Matrix Team Leadership

    • Develop and execute safety strategies for products in both clinical development and post-marketing settings.
    • Anticipate, detect, and address product safety issues, ensuring appropriate implementation of risk-reduction strategies.
    • Facilitate safety governance and establish cross-functional teams to address product safety issues, ensuring integration into clinical study protocols and product labeling.
    • Represent GSK on Clinical Matrix and Project Teams, addressing urgent safety issues and leading process improvement initiatives.
    • Author or contribute to updates of written standards, such as SOPs, to ensure adherence to policies and regulations.
    • Build strong relationships and demonstrate leadership within a matrix team, including coaching and mentoring.

    Communication and Influencing

    • Lead presentations on safety recommendations and issues to senior staff and external stakeholders, including regulatory authorities and licensing partners.
    • Drive cross-functional process improvement within GSK, contributing to long-term strategy and business improvements.
    • Prepare for audits and inspections, ensuring readiness and effective communication.

    Basic Qualifications

    • Undergraduate degree in a medical or health science discipline; advanced degree preferred.
    • Extensive experience in the pharmaceutical or biotech industry, with a focus on Medical Affairs, Pharmacovigilance, or Drug Safety.
    • Significant experience in safety evaluation and risk management, including clinical development and post-marketing activities.
    • Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development processes.
    • Experience working in large matrix organizations.

    Preferred Qualifications

    • Advanced Degree in Life Sciences or Pharmacovigilance.
    • Proven ability to influence key stakeholders at all levels of the organization.

    Why GSK?

    At GSK, our mission is to unite science, technology, and talent to advance health and tackle disease. We are a global biopharma company dedicated to making a positive impact on billions of lives while delivering strong, sustainable returns for shareholders. We focus on vaccines, specialty and general medicines, with core therapeutic areas including infectious diseases, HIV, respiratory/immunology, and oncology.

    We strive to create a workplace where people feel inspired, valued, and included, where they can grow and take care of their wellbeing. If you share our ambition, join us to be part of a collaborative team that is dedicated to making a global impact.

    Important Notice to Employment Agencies

    GSK does not accept referrals from employment agencies or businesses for vacancies posted on this site without prior written authorization. Any referrals made without authorization will be considered invalid, and GSK will not be liable for any fees arising from such referrals.

    For U.S. Licensed Healthcare Professionals

    If you are a U.S. Licensed Healthcare Professional, GSK may be required to report expenses incurred on your behalf during the interview process to comply with federal and state transparency requirements. For more information, please visit GSK’s Transparency Reporting.

    Apply now to be part of GSK’s journey to get Ahead Together!

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