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Medical Reviewer

Medical Reviewer

ConfidentialMumbai, Kolkata, Delhi
1 day ago
Job 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

      • Skills Required

      Outlook, Word, Excel, Powerpoint, Fda, ich gcp , MHRA

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    Medical Medical • Mumbai, Kolkata, Delhi