Chief Medical Officer: Clinical Safety Specialist

4 days ago

Chennai, Tamil Nadu, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

As a senior medical professional, you will lead our team in clinical and post-marketing drug safety initiatives.

Clinical Phase:
  • Act as a medical monitor/medical expert, ensuring effective communication with clients and support to sites regarding protocol or possible drug interactions.
  • Review and provide feedback on study protocols as needed, delivering therapeutic area training for all case processing teams.
  • Draft medical monitoring plans (MMPs) and ensure compliance.
  • Assess adverse events (AEs), determine appropriate actions, and make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensuring protocol compliance and drafting monthly reports for clients.
  • Develop and update current training materials in line with GCP and GVP requirements.
Post-Marketing (Pharmacovigilance):
  • Support maintenance of medical platforms, including SOPs, manuals, and documents.
  • Lead and support medical reviewers, interacting with client medical teams and clinical teams.
  • Act as the main responsible person at PLG for clients' concerns and escalations.
  • Medical review of ICSRs, supporting causality, medical assessment, and benefit-risk evaluation of medicinal products.
  • Mentor junior medical reviewers and perform additional reviews to ensure competency.
  • Provide feedback and ongoing workshops to develop medical reviewers.
  • Participate in audits and inspections as required.

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