Senior Clinical Expert

15 hours ago

Anand, Gujarat, India beBeeMedicalAdvisor Full time ₹ 18,00,000 - ₹ 19,00,000
Lead Medical Advisor

This role involves leading medical review teams and providing expert guidance on clinical and post-marketing drug safety.

Clinical Phase Responsibilities:

  • Lead medical monitor and medical expert, ensuring effective communication with clients and providing support to sites regarding protocol or possible drug interactions.
  • Review and provide feedback on study protocols, deliver therapeutic area training for all case processing team members, and draft medical monitoring plans (MMP) ensuring compliance.
  • Assess the severity of adverse events (AEs), determine appropriate actions, and make assessments on SUSAR reportability.
  • Perform reviews and interpret clinical data, ensure protocol compliance, and draft monthly reports for clients.

Post-Marketing (Pharmacovigilance) Responsibilities:

  • Support the maintenance of medical platforms, including SOPs, manuals, and documents. Lead and support medical reviewers, interact with clients' medical teams, and act as the main responsible person at PLG for client concerns and escalation.
  • Conduct medical reviews of ICSRs, assess causality, and perform benefit-risk evaluations of medicinal products.
  • Mentor junior medical reviewers, perform additional reviews of cases, and provide feedback and ongoing workshops to develop medical reviewers.

Requirements:

  • Experience in leading medical review teams.
  • Client communications.
  • Safety Database experience.
  • Minimum 10 years experience working for service providers or pharmaceutical company.
  • At least 5-7 years of experience as a Medical Monitor or clinical phase.

Technical Skills:

  • Microsoft package.
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
  • Working knowledge of EDC systems.
  • Good Medical knowledge and Pharmacology understanding.

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