Senior Medical Reviewer Lead

8 hours ago


Dombivli, Maharashtra, India beBeeMedicalExpert Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

We are seeking a seasoned medical expert to lead our team as a senior medical reviewer.

Clinical Phase:

  • Lead medical monitoring activities, including protocol review, therapeutic area training, and adverse event management.
  • Develop and implement effective communication strategies with clients, sites, and internal stakeholders.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements, such as GCP and GVP.

Post-Marketing (Pharmacovigilance):

  • Serve as the primary point of contact for client concerns and escalations.
  • Provide medical review of ICSRs, including causality assessment and benefit-risk evaluation.
  • Mentor junior medical reviewers and perform additional reviews to ensure competency.

Key Requirements:

  • MBBS or MD degree.
  • Minimum 10 years of experience in leading medical review teams, with at least 5-7 years in clinical phase.
  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.

Desirable Skills:

  • Microsoft package proficiency.
  • Working knowledge of EDC systems.

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