Senior Clinical Safety Specialist

3 days ago


Kozhikode, Kerala, India beBeeMedicalExpert Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking a medical expert to lead our drug safety review teams and provide clinical guidance.

Key responsibilities include:

  • Leading medical monitors and providing expertise on study protocols, adverse events, and safety reporting.
  • Delivering therapeutic area training for case processing teams and ensuring compliance with regulatory requirements.
  • Mentoring junior medical reviewers and performing additional reviews to ensure competency.

Additional key areas of responsibility include:

  • Supporting the maintenance of medical platforms, including SOPs, manuals, and documents.
  • Leading and supporting medical reviewers in assessing causality, medical assessment, and benefit-risk evaluation of medicinal products.
  • Training and mentoring other team members on pharmacovigilance principles and regulatory requirements.

Requirements:

  • MBBS or MD degree
  • Minimum 10 years of experience in leading medical review teams, client communications, and safety database management
  • Strong understanding of regulatory requirements related to drug safety
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment


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