Senior Lead Clinical Expert

2 days ago


Mount Abu, Rajasthan, India beBeeClinical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Lead Clinical Expert - Pharmacovigilance and Drug Safety

We are seeking an experienced Senior Lead Clinical Expert to oversee our medical review teams and provide expert guidance on clinical and post-marketing drug safety. The successful candidate will have a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.

  • Clinical Phase Responsibilities:
  • Ensure effective communication with clients, sites, and stakeholders regarding medical monitoring.
  • Review and provide feedback on study protocols, assess protocol deviations, and determine appropriate actions.
  • Deliver therapeutic area training for case processing teams.
  • Develop and update medical monitoring plans, ensuring compliance with GCP and GVP requirements.
  • Perform clinical data reviews, assess protocol compliance, and draft monthly reports for clients.

Post-Marketing (Pharmacovigilance) Responsibilities:

  • Support maintenance of medical platforms, SOPs, manuals, and documents.
  • Lead and support medical reviewers in client interactions, causality assessments, and benefit-risk evaluations.
  • Mentor junior medical reviewers, perform additional reviews, and provide ongoing workshops and feedback.
  • Participate in audits and inspections, ensuring understanding of client needs and expectations.

Requirements:

  • MBBS or MD degree
  • Minimum 10 years of experience in leading medical review teams, client communications, and safety database management.
  • 5-7 years of experience as a Medical Monitor or in clinical phases.
  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.


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