Talent.com
This job offer is not available in your country.
Chief Clinical Expert

Chief Clinical Expert

beBeeMedicalKottayam, Kerala, India
2 days ago
Job description

As a seasoned Clinical Leader, you will oversee the medical aspects of our drug safety initiatives.

Clinical Phase :

  • You will lead a team as a medical monitor and provide expert guidance.
  • Review study protocols and provide valuable feedback when necessary.
  • Deliver comprehensive therapeutic area training to our case processing teams.
  • Evaluate SUSAR reports for relevance.
  • Analyze clinical data, ensure protocol compliance, and compile monthly reports for our clients.

Post-Marketing (Pharmacovigilance) :

  • Support the maintenance of our medical platform, including SOPs, manuals, and documents.
  • Collaborate with our client's medical team and clinical team.
  • Examine ICSRs and contribute to causality assessments, medical evaluations, and benefit-risk assessments.
  • Mentor junior medical reviewers and conduct additional reviews to ensure their competency.
  • Train and mentor other team members.
  • Requirements : MBBS or MD degree. At least 10 years of experience in leading medical review teams. Strong pharmaceutical background and knowledge of GVP, GCP, FDA, and regulatory requirements.

    Create a job alert for this search

    Chief • Kottayam, Kerala, India