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Senior Medical Safety Specialist

2 weeks ago

Cochin, Kerala, India beBeeMedical Full time ₹ 17,51,000 - ₹ 24,30,000
Job Opportunity

This is a critical role within the pharmacovigilance team, responsible for evaluating safety data and determining medical relevance of adverse event reports.

The successful candidate will work closely with our pharmacovigilance specialists to ensure compliance with regulatory requirements and provide expert medical opinion on safety issues.

Key Responsibilities:
  • Conduct thorough medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
  • Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
  • Act as an internal consultant to case processing teams on projects being supported
Qualifications:
  • MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
  • At least three years of experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training is required.
  • A minimum of two years of pharmacovigilance experience is required.