Medical Reviewer - Bengaluru / Bangalore - Thepharmadaily

    Thepharmadaily
    Thepharmadaily Bengaluru / Bangalore

    1 day ago

    Full time
    Description
    • Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including analysis of narrative content, coding, expectedness, seriousness, causality, and company summary to meet service level agreements and regulatory timelines.
    • Edit and medically review Analyses of Similar Events (AOSE) for expedited cases as required by regulatory guidelines.
    • Serve as an internal expert and consultant for the pharmacovigilance case processing teams.
    • Safety Data Analysis
    • Maintain a deep understanding of the scientific basis for therapies, drug-induced diseases, medical devices, vaccines, and the drug development process.
    • Continuously acquire and maintain knowledge of product safety profiles across therapeutic areas and the corresponding regulatory requirements.
    • Conduct process improvement activities, including the implementation of quality control processes and providing feedback to case processors on discrepancies or errors.
    • Training and Mentoring
    • Support training and mentoring for case processing/medical review personnel as required.
    • Actively contribute to the organization s initiatives to meet business and regulatory objectives.
    • Regulatory Compliance
    • Ensure compliance with international regulatory guidelines, including FDA , ICH GCP , MHRA , PMDA , and EU Clinical Trial Directive .
    • Stay informed on medical safety and regulatory industry developments to ensure adherence to changing standards.

    Job Expectations

    • Travel : Less than 5%
    • Hours : 45 hours per week
    • This position may include additional duties as assigned.

    Education and Experience

    • Required Qualifications :
    • MBBS, MD, BDS, or MDS degree.
    • 1-2 years of experience as a Medical Reviewer for ICSRs in the pharmaceutical, biotech, or medical device industries. CRO experience is highly desirable.
    • Skills and Knowledge :
    • Strong understanding of pharmacovigilance regulations, including expertise in international guidelines (FDA, ICH GCP, MHRA, PMDA, GVP, EU Clinical Trial Directive).
    • Excellent interpersonal, organizational, and communication skills (both written and verbal).
    • Proficiency in MS Office applications (Outlook, Excel, Word, PowerPoint).

    Cultural Beliefs at EVERSANA

    • Patient Minded : We act with the patient s best interest in mind.
    • Client Delight : We own every client experience and its impact on results.
    • Take Action : We are empowered and empower others to act now.
    • Grow Talent : We own our development and invest in the development of others.
    • Win Together : We passionately connect with anyone, anywhere, anytime to achieve results.
    • Communication Matters : We create transparent, thoughtful, and timely dialogue.
    • Embrace Diversity : We create an environment of awareness and respect.
    • Always Innovate : We are bold and creative in everything we do

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